Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 143 for:    acne AND erythema

An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02173054
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : February 26, 2016
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne
Interventions Other: Adapalene gel with Eucerin
Other: Adapalene gel
Other: Adapalene gel with placebo moisturizer
Enrollment 120
Recruitment Details The recruitment period: between June 2014 and December 2014 Location: Department of Dermatology, Siriraj Hospital, Mahidol University, Thailand
Pre-assignment Details  
Arm/Group Title Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Hide Arm/Group Description

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face

Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face

Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face

Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Period Title: Overall Study
Started 40 40 40
Completed 39 40 39
Not Completed 1 0 1
Reason Not Completed
lack of compliance             1             0             0
Withdrawal by Subject             0             0             1
Arm/Group Title Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin Total
Hide Arm/Group Description

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face

Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face

Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face

Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Total of all reporting groups
Overall Number of Baseline Participants 40 40 40 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 40 participants 120 participants
27.3
(19 to 43)
27.2
(20 to 40)
28.1
(18 to 49)
27.5
(18 to 49)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
Female
22
  55.0%
19
  47.5%
26
  65.0%
67
  55.8%
Male
18
  45.0%
21
  52.5%
14
  35.0%
53
  44.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 40 participants 40 participants 40 participants 120 participants
40 40 40 120
1.Primary Outcome
Title Reduction of Undesirable Effects
Hide Description
  • Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.
  • The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown.
Time Frame 2nd week, 4th week, and 8th week
Hide Outcome Measure Data
Hide Analysis Population Description
The reasons for drop out were lack of compliance (n=1, group A: adapalene gel alone) and consent withdrawal at patient's request (n=1, group C: adapalene with Eucerin)
Arm/Group Title Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Hide Arm/Group Description:

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face

Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face

Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face

Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Overall Number of Participants Analyzed 39 40 39
Measure Type: Number
Unit of Measure: participants
Erythema (none) 26 38 35
Erythema (mild) 10 2 4
Erythema (moderate) 3 0 0
Dryness (none) 21 29 32
Dryness (mild) 14 11 6
Dryness (moderate) 4 0 1
Scaling (none) 13 16 24
Scaling (mild) 22 24 14
Scaling (moderate) 4 0 1
Stinging (none) 6 9 6
Stinging (mild) 14 12 11
Stinging (moderate) 10 13 13
Stinging (severe) 9 6 9
Pruritus (none) 18 21 23
Pruritus (mild) 10 8 9
Pruritus (moderate) 7 6 5
Pruritus (severe) 4 5 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments This statistical analysis was used to compare number of participants who had erythema among 3 groups.
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments This statistical analysis was used to compare number of participants who had dryness among 3 groups
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments This statistical analysis was used to compare number of participants who had scaling among 3 groups.
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments This statistical analysis was used to compare number of participants who had stinging among 3 groups.
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments This statistical analysis was used to compare number of participants who had pruritus among 3 groups.
Method Kruskal-Wallis
Comments [Not Specified]
2.Primary Outcome
Title Skin Tolerability: Skin Sebum Content and Skin Hydration
Hide Description Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively
Time Frame Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Hide Arm/Group Description:

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face

Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face

Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face

Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Overall Number of Participants Analyzed 39 40 39
Mean (Standard Deviation)
Unit of Measure: µg/cm^2
Baseline Sebumeter 75.7  (34.4) 71.2  (42.4) 73.7  (31.2)
Week 8 Sebumeter 63.6  (31.7) 59.9  (55.3) 64.2  (35.0)
Baseline Corneometer 51.7  (10.0) 50.2  (10.5) 46.7  (11.3)
Week 8 Corneometer 50.9  (10.9) 49.5  (9.4) 48.6  (9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Placebo Moisturizer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with placebo moisturizer group
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with Eucerin group
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adapalene Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.978
Comments This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel group
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Placebo Moisturizer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.273
Comments This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with placebo moisturizer group
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.735
Comments This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with Eucerin group.
Method Paired t-test
Comments [Not Specified]
3.Primary Outcome
Title Skin Tolerability: Transepidermal Water Loss (TEWL)
Hide Description Skin tolerability was assessed by measuring TEWL with the Tewameter TM300
Time Frame Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Hide Arm/Group Description:

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face

Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face

Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face

Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Overall Number of Participants Analyzed 39 40 39
Mean (Standard Deviation)
Unit of Measure: g/m^2h
Baseline TEWL 9.8  (3.3) 10.4  (4.6) 10.6  (3.7)
Week 8 TEWL 12.3  (4.8) 11.8  (5.4) 11.5  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Placebo Moisturizer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with placebo moisturizer group.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with Eucerin group.
Method Paired t-test
Comments [Not Specified]
4.Secondary Outcome
Title Reduction of Severity of Acne
Hide Description
  • Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks
  • Total acne lesions = inflammatory + noninflammatory acne lesions
  • Reduction of lesions counts are considered to be a better outcome
Time Frame baseline, 2nd week, 4th week and 8th week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Hide Arm/Group Description:

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face

Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face

Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face

Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Overall Number of Participants Analyzed 39 40 39
Mean (Standard Deviation)
Unit of Measure: Lesions
Baseline Total Lesion Count 35.9  (49.1) 27.4  (37.0) 25.5  (16.9)
Week 2 Total Lesion Count 41  (65.7) 26.6  (29.3) 23.8  (16.6)
Week 4 Total Lesion Count 39  (54.2) 27.3  (25.2) 25.7  (16.7)
Week 8 Total Lesion Count 28.9  (33.3) 26.8  (22.5) 19.9  (15.2)
Baseline Inflammatory Lesion Counts 3.5  (3.9) 3  (2.6) 3.8  (3.3)
Week 2 Inflammatory Lesion Counts 4.5  (6.6) 4.1  (7.4) 3.6  (3.9)
Week 4 Inflammatory Lesion Counts 3.6  (5.4) 2.9  (2.9) 3.4  (3.5)
Week 8 Inflammatory Lesion Counts 2.5  (5.6) 3.1  (4.1) 2.4  (3.0)
Baseline Noninflammatory Counts 32.4  (48.0) 24.5  (37.3) 21.6  (16.2)
Week 2 Noninflammatory Counts 36.5  (61.9) 22.5  (28.1) 20.5  (15.3)
Week 4 Noninflammatory Counts 35.4  (50.6) 24.4  (24.4) 22.6  (16.1)
Week 8 Noninflammatory Counts 26.4  (29.1) 23.7  (20.1) 17.7  (14.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Placebo Moisturizer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.697
Comments This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adapalene Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Placebo Moisturizer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.755
Comments This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Adapalene Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Placebo Moisturizer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.576
Comments This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
5.Secondary Outcome
Title Reduction of Severity of Acne: Acne Severity Index (ASI)
Hide Description
  • The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)
  • Decrease of ASI score are considered to be a better outcome
Time Frame baseline, 2nd week, 4th week and 8th week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Hide Arm/Group Description:

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face

Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face

Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face

Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Overall Number of Participants Analyzed 39 40 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline ASI 11.7  (13.6) 9.4  (9.5) 9.5  (5.8)
Week 2 ASI 14.4  (20.8) 10.4  (11.3) 8.7  (6.1)
Week 4 ASI 13.6  (19.4) 9.2  (7.5) 9.2  (5.9)
Week 8 ASI 9.5  (13.7) 9.3  (8.5) 7.1  (5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapalene Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Placebo Moisturizer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.606
Comments This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adapalene Gel With Eucerin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.
Method wilcoxan signed ranks test
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Hide Arm/Group Description

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face

Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply placebo cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply placebo cream all over the face

Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Morning

  • Wash face by prepared facial foam and dry their face
  • Apply Eucerin cream all over the face

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
  • Apply Eucerin cream all over the face

Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

All-Cause Mortality
Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adapalene Gel Adapalene Gel With Placebo Moisturizer Adapalene Gel With Eucerin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Papapit Tuchinda
Organization: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Phone: +662-419-4333
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02173054     History of Changes
Other Study ID Numbers: Acne and adjuctive moisturizer
First Submitted: June 18, 2014
First Posted: June 24, 2014
Results First Submitted: July 29, 2015
Results First Posted: February 26, 2016
Last Update Posted: January 23, 2017