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Trial record 73 of 134 for:    acne AND peroxide

Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01951417
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Acne
Interventions Drug: Adapalene/BPO Gel
Other: Moisturizer SPF 30
Other: Foam Wash
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adapalene/BPO Gel/Foam Wash/Moisturizer
Hide Arm/Group Description

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Moisturizer SPF 30: Moisturizer SPF 30 (once daily)

Foam Wash: Foam Wash (twice daily)

Period Title: Overall Study
Started 81
Completed 72
Not Completed 9
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             2
Lost to Follow-up             6
Arm/Group Title Adapalene/BPO Gel/Foam Wash/Moisturizer
Hide Arm/Group Description

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Moisturizer SPF 30: Moisturizer SPF 30 (once daily)

Foam Wash: Foam Wash (twice daily)

Overall Number of Baseline Participants 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants
19.0  (7.8)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Female
40
  49.4%
Male
41
  50.6%
[1]
Measure Description: Safety Population
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
American Indian or Alaska Native
1
   1.2%
Asian
4
   4.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
24
  29.6%
White
48
  59.3%
More than one race
0
   0.0%
Unknown or Not Reported
4
   4.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Hispanic or Latino
17
  21.0%
Not Hispanic or Latino
64
  79.0%
Unknown or Not Reported
0
   0.0%
Skin Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants
Dry 5
Normal 22
Oily 32
Combination 22
Fitzpatrick Skin Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants
I 3
II 20
III 16
IV 19
V 13
VI 10
[1]
Measure Description:

Investigator assessment based on the standard Fitzpatrick Skin Type Scale (I to VI).

TYPE 1: Highly sensitive, always burns, never tans. TYP E 2: Very sun sensitive, burns easily, tans minimally. TYPE 3: Sun sensitive skin, sometimes burns, slowly tans to light brown. TYPE 4: Minimally sun sensitive, burns minimally, always tans to moderate brown.

TYPE 5: Sun insensitive skin, rarely burns, tans well. TYPE 6: Sun insensitive, never burns, deeply pigmented.

--------------------------------------------------------------------------------

History of Acne  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants
4.4  (4.7)
1.Primary Outcome
Title Total Lesion Count
Hide Description The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Time Frame Baseline, 2, 4, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all subjects who had at least 1 post-treatment administration evaluation)
Arm/Group Title Adapalene/BPO Gel/Foam Wash/Moisturizer
Hide Arm/Group Description:

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Moisturizer SPF 30: Moisturizer SPF 30 (once daily)

Foam Wash: Foam Wash (twice daily)

Overall Number of Participants Analyzed 77
Mean (Standard Deviation)
Unit of Measure: lesions
Baseline 76.7  (21.1)
Week 2 53.9  (25.5)
Week 4 50.0  (27.8)
Week 8 43.7  (22.7)
2.Secondary Outcome
Title Inflammatory Lesions
Hide Description The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Time Frame Baseline, 2, 4, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all subjects who had at least 1 post-treatment administration evaluation)
Arm/Group Title Adapalene/BPO Gel/Foam Wash/Moisturizer
Hide Arm/Group Description:

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Moisturizer SPF 30: Moisturizer SPF 30 (once daily)

Foam Wash: Foam Wash (twice daily)

Overall Number of Participants Analyzed 77
Mean (Standard Deviation)
Unit of Measure: lesions
Baseline 27.3  (6.4)
Week 2 17.4  (9.0)
Week 4 15.7  (11.3)
Week 8 14.4  (9.5)
3.Secondary Outcome
Title Non-inflammatory Lesions
Hide Description The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks
Time Frame Baseline, 2, 4, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all subjects who had at least 1 post-treatment administration evaluation)
Arm/Group Title Adapalene/BPO Gel/Foam Wash/Moisturizer
Hide Arm/Group Description:

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Moisturizer SPF 30: Moisturizer SPF 30 (once daily)

Foam Wash: Foam Wash (twice daily)

Overall Number of Participants Analyzed 77
Mean (Standard Deviation)
Unit of Measure: lesions
Baseline 49.4  (18.3)
Week 2 36.4  (21.5)
Week 4 34.1  (23.4)
Week 8 29.2  (18.3)
4.Secondary Outcome
Title Subject Questionnaire
Hide Description Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time Frame Baseline, 2, 4, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all subjects who had at least 1 post-treatment administration evaluation)
Arm/Group Title Adapalene/BPO Gel/Foam Wash/Moisturizer
Hide Arm/Group Description:

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Moisturizer SPF 30: Moisturizer SPF 30 (once daily)

Foam Wash: Foam Wash (twice daily)

Overall Number of Participants Analyzed 77
Measure Type: Number
Unit of Measure: participants
Very satisfied 23
Satisfied 42
Undecided 5
Dissatisfied 3
Very dissatisfied 1
Missing 3
5.Other Pre-specified Outcome
Title Erythema
Hide Description Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time Frame Baseline, 2, 4, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
As observed population
Arm/Group Title Baseline Week 2 Week 4 Week 8
Hide Arm/Group Description:

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)
Overall Number of Participants Analyzed 81 76 76 72
Measure Type: Number
Unit of Measure: participants
None 50 49 45 52
Mild 28 20 26 18
Moderate 3 7 5 2
Severe 0 0 0 0
6.Other Pre-specified Outcome
Title Scaling
Hide Description Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time Frame Baseline, 2, 4, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
As observed population
Arm/Group Title Baseline Week 2 Week 4 Week 8
Hide Arm/Group Description:

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)
Overall Number of Participants Analyzed 81 76 76 72
Measure Type: Number
Unit of Measure: participants
None 73 57 65 63
Mild 8 15 9 9
Moderate 0 4 2 0
Severe 0 0 0 0
7.Other Pre-specified Outcome
Title Dryness
Hide Description Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time Frame Baseline, 2, 4, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
As observed population
Arm/Group Title Baseline Week 2 Week 4 Week 8
Hide Arm/Group Description:

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)
Overall Number of Participants Analyzed 81 76 76 72
Measure Type: Number
Unit of Measure: participants
None 71 45 56 60
Mild 10 22 19 11
Moderate 0 9 1 1
Severe 0 0 0 0
8.Other Pre-specified Outcome
Title Stinging/Burning
Hide Description Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time Frame Baseline, 2, 4, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
As observed population
Arm/Group Title Baseline Week 2 Week 4 Week 8
Hide Arm/Group Description:

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

  • Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
  • Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
  • Foam Wash: Foam Wash (twice daily)
Overall Number of Participants Analyzed 81 76 76 72
Measure Type: Number
Unit of Measure: participants
None 80 48 63 62
Mild 1 23 12 10
Moderate 0 5 1 0
Severe 0 0 0 0
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene/BPO Gel/Foam Wash/Moisturizer
Hide Arm/Group Description

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Moisturizer SPF 30: Moisturizer SPF 30 (once daily)

Foam Wash: Foam Wash (twice daily)

All-Cause Mortality
Adapalene/BPO Gel/Foam Wash/Moisturizer
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene/BPO Gel/Foam Wash/Moisturizer
Affected / at Risk (%) # Events
Total   0/81 (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/BPO Gel/Foam Wash/Moisturizer
Affected / at Risk (%) # Events
Total   13/81 (16.05%)    
General disorders   
Pain * 1  2/81 (2.47%)  2
Injury, poisoning and procedural complications   
Muscle strain * 1  1/81 (1.23%)  1
Accidental exposure to product by child * 1  1/81 (1.23%)  1
Skin and subcutaneous tissue disorders   
Erythema * 1  6/81 (7.41%)  6
Dry skin * 1  4/81 (4.94%)  4
Skin exfoliation * 1  2/81 (2.47%)  2
Skin irritation * 1  1/81 (1.23%)  1
Skin burning sensatation * 1  1/81 (1.23%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
  • Open label study with small sample size
  • Short study duration
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Elizabeth M Nieman
Organization: Galderma Labratories, L.P.
Phone: 817-961-5130
EMail: elizabeth.nieman@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01951417     History of Changes
Other Study ID Numbers: GLI.04.SRE.04.US10268
First Submitted: September 23, 2013
First Posted: September 26, 2013
Results First Submitted: July 8, 2014
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016