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Trial record 97 of 340 for:    acne AND facial

Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

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: NCT00926367
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : August 4, 2011
Last Update Posted : May 20, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Clindamycin and benzoyl peroxide
Drug: benzoyl peroxide 2.5% and adapalene 0.1% gel
Enrollment 52
Recruitment Details Clinical research center.
Pre-assignment Details Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.
Arm/Group Title Duac Epiduo
Hide Arm/Group Description Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Period Title: Overall Study
Started 25 27
Completed 23 24
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             1             0
Skin Irritation             1             2
Arm/Group Title Duac Epiduo Total
Hide Arm/Group Description Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene Total of all reporting groups
Overall Number of Baseline Participants 25 27 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
<=18 years
1
   4.0%
1
   3.7%
2
   3.8%
Between 18 and 65 years
24
  96.0%
26
  96.3%
50
  96.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Female
23
  92.0%
26
  96.3%
49
  94.2%
Male
2
   8.0%
1
   3.7%
3
   5.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 27 participants 52 participants
25 27 52
1.Primary Outcome
Title Skin Erythema (Redness)
Hide Description

Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.

Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 1.56  (0.92) 1.89  (1.01)
Day 1 2.62  (1.32) 2.65  (0.94)
Day 2 2.90  (1.23) 2.52  (1.03)
Day 3 3.08  (1.23) 2.81  (1.02)
Day 6 3.17  (1.33) 3.13  (0.89)
Day 7 3.07  (1.30) 3.08  (1.01)
Day 8 2.87  (1.24) 2.98  (1.08)
Day 9 2.78  (1.36) 3.03  (0.99)
Day 10 2.89  (1.22) 2.94  (1.02)
Day 13 2.85  (1.20) 2.83  (1.21)
Day 14 2.73  (1.20) 2.56  (1.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac, Epiduo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Dunn's Multiple Comparisons Test
Comments A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.
2.Primary Outcome
Title Skin Dryness
Hide Description

The amount of dryness on the left and right cheek of each panelist.

The scale used to evaluate skin dryness is:

Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring

Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.12  (0.44) 0.07  (0.27)
Day 1 0.41  (0.85) 0.25  (0.57)
Day 2 0.32  (0.83) 0.34  (0.59)
Day 3 0.46  (0.91) 0.55  (1.15)
Day 6 0.61  (1.02) 1.73  (1.76)
Day 7 0.69  (1.16) 1.85  (2.01)
Day 8 0.60  (1.13) 1.87  (2.04)
Day 9 0.73  (1.28) 2.29  (1.99)
Day 10 0.56  (1.04) 1.49  (1.77)
Day 13 0.80  (1.33) 1.26  (1.85)
Day 14 0.79  (1.04) 1.33  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac, Epiduo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.
Method Dunn's Multiple Comparisons Test
Comments [Not Specified]
3.Secondary Outcome
Title Skin Moisture and Hydration
Hide Description

To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.

Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss.

Time Frame Baseline, Days 3, 7, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: TEWL rates (gm/m2/hr)
Baseline 11.50  (3.65) 13.07  (5.06)
Day 3 11.38  (2.49) 15.85  (9.12)
Day 7 14.51  (3.65) 21.65  (8.66)
Day 14 13.36  (3.33) 19.28  (8.10)
4.Secondary Outcome
Title Skin Hydration
Hide Description

The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.

Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.

Time Frame Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: Microsiemens
Baseline 378.06  (131.08) 392.09  (162.16)
4 hrs Post 1st Treatment 323.47  (154.30) 415.90  (197.57)
Day 3 420.97  (122.60) 465.25  (175.65)
Day 7 385.91  (156.69) 414.77  (154.46)
Day 14 401.98  (156.08) 418.51  (139.64)
5.Secondary Outcome
Title Self Assessment of Burning
Hide Description

The amount of burning on the left and right cheek of each panelist.

The scale used to evaluate burning is:

Scale Description:

(scale: 0 = none to 3 = severe)

Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Patients Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Patients Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.00  (0.00) 0.00  (0.00)
Day 1 0.04  (0.20) 0.04  (0.19)
Day 2 0.04  (0.20) 0.04  (0.19)
Day 3 0.12  (0.33) 0.15  (0.36)
Day 6 0.12  (0.33) 0.56  (0.85)
Day 7 0.17  (0.48) 0.70  (0.87)
Day 8 0.17  (0.48) 0.50  (0.81)
Day 9 0.13  (0.45) 0.27  (0.67)
Day 10 0.13  (0.45) 0.31  (0.68)
Day 13 0.08  (0.28) 0.35  (0.75)
Day 14 0.08  (0.28) 0.19  (0.57)
6.Secondary Outcome
Title Self Assessment of Stinging
Hide Description

The amount of stinging on the left and right cheek of each panelist.

The scale used to evaluate stinging is:

Scale Description:

(scale: 0 = none to 3 = severe)

Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.00  (0.00) 0.00  (0.00)
Day 1 0.08  (0.28) 0.00  (0.00)
Day 2 0.08  (0.28) 0.00  (0.00)
Day 3 0.12  (0.44) 0.04  (0.19)
Day 6 0.1  (0.4) 0.4  (0.8)
Day 7 0.17  (0.48) 0.30  (0.67)
Day 8 0.17  (0.48) 0.35  (0.69)
Day 9 0.13  (0.45) 0.15  (0.54)
Day 10 0.13  (0.45) 0.12  (0.43)
Day 13 0.13  (0.34) 0.19  (0.57)
Day 14 0.08  (0.28) 0.12  (0.43)
7.Secondary Outcome
Title Self Assessment of Dryness
Hide Description

The amount of dryness on the left and right cheek of each panelist.

The scale used to evaluate dryness is:

Scale Description:

(scale: 0 = none to 3 = severe)

Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.24  (0.44) 0.30  (0.54)
Day 1 0.2  (0.4) 0.19  (0.40)
Day 2 0.16  (0.37) 0.15  (0.36)
Day 3 0.24  (0.44) 0.2  (0.4)
Day 6 0.48  (0.77) 0.67  (0.96)
Day 7 0.54  (0.72) 0.70  (0.91)
Day 8 0.54  (0.78) 0.81  (1.02)
Day 9 0.54  (0.78) 0.85  (1.01)
Day 10 0.50  (0.78) 0.69  (0.88)
Day 13 0.50  (0.78) 0.73  (0.96)
Day 14 0.46  (0.72) 0.69  (1.05)
8.Secondary Outcome
Title Self Assessment of Texture (Roughness)
Hide Description

The amount of roughness on the left and right cheek of each panelist.

The scale used to evaluate roughness is:

Scale Description:

(scale: 0 = none to 3 = severe)

Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.28  (0.54) 0.15  (0.36)
Day 1 0.20  (0.50) 0.07  (0.27)
Day 2 0.16  (0.47) 0.07  (0.27)
Day 3 0.32  (0.69) 0.07  (0.27)
Day 6 0.28  (0.68) 0.33  (0.78)
Day 7 0.33  (0.76) 0.19  (0.56)
Day 8 0.25  (0.61) 0.3  (0.7)
Day 9 0.29  (0.69) 0.15  (0.46)
Day 10 0.29  (0.69) 0.15  (0.46)
Day 13 0.33  (0.70) 0.12  (0.43)
Day 14 0.29  (0.69) 0.15  (0.46)
9.Secondary Outcome
Title Self Assessment of Pain
Hide Description

The amount of pain on the left and right cheek of each panelist.

The scale used to evaluate pain is:

Scale Description:

(scale: 0 = none to 3 = severe)

Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.00  (0.00) 0.00  (0.00)
Day 1 0.04  (0.20) 0.04  (0.19)
Day 2 0.04  (0.20) 0.00  (0.00)
Day 3 0.04  (0.20) 0.00  (0.00)
Day 6 0.04  (0.20) 0.1  (0.4)
Day 7 0.04  (0.20) 0.04  (0.19)
Day 8 0.04  (0.20) 0.04  (0.20)
Day 9 0.04  (0.20) 0.00  (0.00)
Day 10 0.04  (0.20) 0.00  (0.00)
Day 13 0.04  (0.20) 0.00  (0.00)
Day 14 0.04  (0.20) 0.00  (0.00)
10.Secondary Outcome
Title Self Assessment of Crusting
Hide Description

The amount of crusting on the left and right cheek of each panelist.

The scale used to evaluate crusting is:

Scale Description:

(scale: 0 = none to 3 = severe)

Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.00  (0.00) 0.00  (0.00)
Day 1 0.00  (0.00) 0.00  (0.00)
Day 2 0.00  (0.00) 0.00  (0.00)
Day 3 0.00  (0.00) 0.00  (0.00)
Day 6 0.00  (0.00) 0.07  (0.38)
Day 7 0.00  (0.00) 0.04  (0.19)
Day 8 0.00  (0.00) 0.04  (0.20)
Day 9 0.00  (0.00) 0.04  (0.20)
Day 10 0.00  (0.00) 0.04  (0.20)
Day 13 0.00  (0.00) 0.00  (0.00)
Day 14 0.00  (0.00) 0.00  (0.00)
11.Secondary Outcome
Title Self Assessment of Blistering
Hide Description

The amount of blistering on the left and right cheek of each panelist.

The scale used to evaluate blistering is:

Scale Description:

(scale: 0 = none to 3 = severe)

Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.00  (0.00) 0.00  (0.00)
Day 1 0.00  (0.00) 0.00  (0.00)
Day 2 0.00  (0.00) 0.00  (0.00)
Day 3 0.00  (0.00) 0.00  (0.00)
Day 6 0.00  (0.00) 0.07  (0.38)
Day 7 0.00  (0.00) 0.04  (0.19)
Day 8 0.00  (0.00) 0.00  (0.00)
Day 9 0.00  (0.00) 0.00  (0.00)
Day 10 0.00  (0.00) 0.00  (0.00)
Day 13 0.00  (0.00) 0.00  (0.00)
Day 14 0.00  (0.00) 0.00  (0.00)
12.Secondary Outcome
Title Self Assessment of Oiliness
Hide Description

The amount of oiliness on the left and right cheek of each panelist.

The scale used to evaluate oiliness is:

Scale Description:

(scale: 0 = none to 3 = severe)

Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

Time Frame Baseline, Day 1 through Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.12  (0.33) 0.19  (0.40)
Day 1 0.08  (0.28) 0.11  (0.42)
Day 2 0.00  (0.00) 0.04  (0.19)
Day 3 0.08  (0.28) 0.11  (0.42)
Day 6 0.04  (0.20) 0.04  (0.19)
Day 7 0.00  (0.00) 0.07  (0.27)
Day 8 0.00  (0.00) 0.04  (0.20)
Day 9 0.00  (0.00) 0.08  (0.27)
Day 10 0.00  (0.00) 0.0  (0.2)
Day 13 0.00  (0.00) 0.12  (0.43)
Day 14 0.00  (0.00) 0.08  (0.27)
13.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
Hide Description

The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?

The subject replied using the following scale:

  1. - Very Comfortable
  2. - Comfortable
  3. - Somewhat Comfortable
  4. - Somewhat Uncomfortable
  5. - Uncomfortable
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.38  (1.13) 2.23  (1.24)
14.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
Hide Description

The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?

The subject replied using the following scale:

0 - Not Compliant at all (<50%)

  1. - Mostly Compliant (50%-79%)
  2. - Very Compliant (80%-100%)
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.00  (0.00) 2.00  (0.00)
15.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
Hide Description

The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?

The subject replied using the following scale:

1 - Yes 0 - No

Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.58  (0.50) 0.54  (0.51)
16.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
Hide Description

The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?

The subject replied using the following scale:

0 - Not Applicable

  1. - Very Easy
  2. - Easy
  3. - Neutral
  4. - Difficult
  5. - Very Difficult
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.04  (1.12) 1.46  (1.14)
17.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
Hide Description

The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?

The subject replied using the following scale:

  1. - Very Satisfied
  2. - Satisfied
  3. - Neutral
  4. - Unsatisfied
  5. - Very Unsatisfied
Time Frame Day 14
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[Not Specified]
Arm/Group Title Duac Epiduo
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Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.29  (1.04) 2.46  (1.03)
18.Secondary Outcome
Title Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
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The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?

The subject replied using the following scale:

0 - Not Applicable

  1. - Very Easy
  2. - Easy
  3. - Neutral
  4. - Difficult
  5. - Very Difficult
Time Frame Day 14
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[Not Specified]
Arm/Group Title Duac Epiduo
Hide Arm/Group Description:
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.17  (0.38) 1.00  (0.00)
Time Frame 14 days
Adverse Event Reporting Description Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
 
Arm/Group Title Duac Epiduo
Hide Arm/Group Description Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
All-Cause Mortality
Duac Epiduo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duac Epiduo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
Duac Epiduo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/25 (52.00%)      13/27 (48.15%)    
General disorders     
Toothache * 1  2/25 (8.00%)  2 1/27 (3.70%)  1
Sore throat * 1  2/25 (8.00%)  2 3/27 (11.11%)  3
Infections and infestations     
Upper respiratory tract infection * 1  2/25 (8.00%)  2 0/27 (0.00%)  0
Seaonal allergies * 1  1/25 (4.00%)  1 0/27 (0.00%)  0
Earache * 1  0/25 (0.00%)  0 3/27 (11.11%)  3
Injury, poisoning and procedural complications     
Stitches contusion * 1  0/25 (0.00%)  0 1/27 (3.70%)  1
Scratched cornea * 1  0/25 (0.00%)  0 1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders     
Joint stiffness * 1  0/25 (0.00%)  0 2/27 (7.41%)  2
Menstrual cramps * 1  3/25 (12.00%)  3 2/27 (7.41%)  2
Nervous system disorders     
Headache * 1  4/25 (16.00%)  4 5/27 (18.52%)  5
Psychiatric disorders     
Insomnia * 1  3/25 (12.00%)  3 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
Irritation * 1  2/25 (8.00%)  2 2/27 (7.41%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00926367     History of Changes
Other Study ID Numbers: C0000-405
First Submitted: June 21, 2009
First Posted: June 23, 2009
Results First Submitted: September 7, 2010
Results First Posted: August 4, 2011
Last Update Posted: May 20, 2015