Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00671749
• Collaborator: (none)
• Enrollment: 100
• Locations: 4
• Arm: 1
• Duration (Months): 8
• Patients Per Site: 25
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: adapalene gel, 0.3%; Drug: clindamycin/benzoyl peroxide gel	Phase 4

Detailed Description

Same as above.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Treatment adapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning	Drug: adapalene gel, 0.3%; Applied once daily at bedtime; Other Names: Differin® Gel, 0.3% ; Drug: clindamycin/benzoyl peroxide gel; Applied once daily in the morning; Other Names: Duac® Gel

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Total Lesion Counts [6 and 12 weeks]

Secondary Outcome Measures

1. Global Severity Assessment Success [6 and 12 weeks]

   Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear

2. Global Assessment of Improvement From Baseline [12 weeks]

3. Worst Post Baseline Tolerability Assessment - Erythema [12 weeks]

   Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

4. Worst Post Baseline Tolerability Assessment - Scaling [12 weeks]

   Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

5. Worst Post Baseline Tolerability Assessment - Dryness [12 weeks]

   Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

6. Worst Post Baseline Tolerability Assessment - Burning/Stinging [12 weeks]

   Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects with a minimum of 20 inflammatory lesions on the face;

2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;

3. Subject has a Global Severity Assessment

Exclusion Criteria:

1. Subjects with more than three nodulo-cystic lesions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Dermatology and Laser Surgery	Sacramento	California	United States	95819
2	Derm Research, P.L.L.C.	Louisville	Kentucky	United States	40217
3	Brodell Medical	Warren	Ohio	United States	44483
4	Northwest Cutaneous Research Specialists	Portland	Oregon	United States	97210

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Ron W Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT00671749
• Other Study ID Numbers: US10066
• First Posted: May 5, 2008
• Last Update Posted: Aug 23, 2022
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Acne Vulgaris; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene; Benzoyl Peroxide

Study Results

Participant Flow

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Period Title: Overall Study
STARTED	100
COMPLETED	92
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Overall Participants	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	18.2 (5.40)
Sex: Female, Male (Count of Participants)
Female	56 56%
Male	44 44%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1%
Asian	2 2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	10 10%
White	77 77%
More than one race	10 10%
Unknown or Not Reported	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 7%
Not Hispanic or Latino	93 93%
Unknown or Not Reported	0 0%
Duration of Acne (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.0 (3.91)
Fitzpatrick Skin Type (participants) [Number]
I	1 1%
II	27 27%
III	38 38%
IV	22 22%
V	4 4%
VI	8 8%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Total Lesion Counts
Time Frame	6 and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Measure Participants	100
Week 6	-47 (24.43)
Week 12	-64 (24.07)

2. Secondary Outcome

Title	Global Severity Assessment Success
Description	Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
Time Frame	6 and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Measure Participants	100
Week 6	8 8%
Week 12	42 42%

3. Secondary Outcome

Title	Global Assessment of Improvement From Baseline
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Measure Participants	100
Clear	3 3%
Almost Clear	40 40%
Marked Improvement	27 27%
Moderate Improvement	16 16%
Minimal Improvement	5 5%
No Change	8 8%
Worse	1 1%

4. Secondary Outcome

Title	Worst Post Baseline Tolerability Assessment - Erythema
Description	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Population (n=99)

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Measure Participants	99
None	29 29%
Mild	37 37%
Moderate	33 33%
Severe	0 0%

5. Secondary Outcome

Title	Worst Post Baseline Tolerability Assessment - Scaling
Description	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Population (n=99)

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Measure Participants	99
None	53 53%
Mild	27 27%
Moderate	16 16%
Severe	3 3%

6. Secondary Outcome

Title	Worst Post Baseline Tolerability Assessment - Dryness
Description	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Population (n=99)

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Measure Participants	99
None	49 49%
Mild	27 27%
Moderate	20 20%
Severe	3 3%

7. Secondary Outcome

Title	Worst Post Baseline Tolerability Assessment - Burning/Stinging
Description	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Population (n=99)

Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
Measure Participants	99
None	67 67%
Mild	18 18%
Moderate	9 9%
Severe	5 5%

Adverse Events

Time Frame	12 Weeks
Adverse Event Reporting Description	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Arm/Group Title	Combination Therapy
Arm/Group Description	Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
All Cause Mortality
	Combination Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Combination Therapy
	Affected / at Risk (%)	# Events
Total	0/99 (0%)
Other (Not Including Serious) Adverse Events
	Combination Therapy
	Affected / at Risk (%)	# Events
Total	32/99 (32.3%)
General disorders
Application Site Burn	32/99 (32.3%)
Application Site Dryness	24/99 (24.2%)
Application Site Erythema	10/99 (10.1%)
Application Site Exfoliation	7/99 (7.1%)
Application Site Discomfort	6/99 (6.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.