Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00599521
• Collaborator: (none)
• Enrollment: 1,067
• Locations: 34
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 31.4
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Adapalene lotion 0.1%; Drug: Adapalene Lotion Vehicle	Phase 3

Detailed Description

This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1067 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate the Efficacy and Safety of Adapalene Lotion, 0.1% Compared With Vehicle Lotion in Subjects With Acne Vulgaris
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adapalene lotion 0.1%	Drug: Adapalene lotion 0.1%; Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Placebo Comparator: Adapalene Lotion vehicle	Drug: Adapalene Lotion Vehicle; Vehicle will be applied topically to the face, once a day, for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 [From Baseline to Week 12]

   Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.

2. Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 [Baseline to 12 weeks]

3. Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [Baseline to Week 12]

4. Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [Baseline to Week 12]

Secondary Outcome Measures

1. Mean Percent Change in Total Lesion Count From Baseline to Week 12 [From Baseline to 12 weeks]

   Percent change in lesion count from baseline to week 12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with Moderate or Severe Acne Vulgaris,

• 20-50 papules and pustules in total on the face excluding the nose

• 30-100 non-inflammatory lesions on the face excluding the nose.

• Negative urine pregnancy test for all females.

Exclusion Criteria:

• Subjects with more than one acne nodule.

• Subjects with any acne cyst on the face.

• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.

• Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.

• Subjects who are pregnant, nursing, or planning a pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	San Diego	California	United States	92123
2	Dermatology Specialists, Inc.	Vista	California	United States	92083
3	Cherry Creek Dermatology	Denver	Colorado	United States	80246
4	Advanced Dermatology and Cosmetic Surgery	Ormond Beach	Florida	United States	32174
5	Dermatology Research	Pinellas Park	Florida	United States	33781
6	Christie Clinic, PC	Champaign	Illinois	United States	61820
7	Compliant Clinical Research	Olathe	Kansas	United States	66061
8	Dermatology Specialists	Louisville	Kentucky	United States	40202
9	East Coast Clinical Research, Inc.	Haverhill	Massachusetts	United States	01830
10	Midwest Cutaneous Research	Clinton Township	Michigan	United States	48038
11	Henry Ford Medical Center-Dept. of Dermatology	Detroit	Michigan	United States	48202
12	Minnesota Clinical Study Centert	Fridley	Minnesota	United States	55432
13	Skin Specialists, PC	Omaha	Nebraska	United States	68144
14	Cindy Lamerson	Reno	Nevada	United States	89511
15	Fran Cook-Bolden	New York	New York	United States	10021
16	Dermatology Associates of Rochester	Rochester	New York	United States	14623
17	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
18	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
19	University Dermatology Consultants	Cincinnati	Ohio	United States	45219
20	Central Sooner Research	Norman	Oklahoma	United States	73069
21	Northwest Cutaneous Research Specialists	Portland	Oregon	United States	97210
22	Palmetto Medical Research	Mount Pleasant	South Carolina	United States	29464
23	Dermatology Associates	Knoxville	Tennessee	United States	37917
24	Dermatology Research Associates	Nashville	Tennessee	United States	37203
25	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
26	J&S Studies, Inc.	Bryan	Texas	United States	77802
27	The Center for Skin Research	Houston	Texas	United States	77056
28	Dermatology Research Center	Salt Lake City	Utah	United States	84124
29	Premier Clinical Research	Spokane	Washington	United States	99204
30	Dermatology Associates	Calgary	Alberta	Canada	T3A 2N1
31	Derm Research @ 888 Inc	Vancouver	British Columbia	Canada	V5Z 3Y1
32	Ultranova Skincare	Barrie	Ontario	Canada	L4M 6L2
33	North Bay Dermatology Centre	North Bay	Ontario	Canada	P1B 3Z7
34	Siena Medical Research	Montreal	Quebec	Canada	H3G 1C6

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00599521
• Other Study ID Numbers: RD.06.SPR.18114; IND 076057
• First Posted: Jan 23, 2008
• Last Update Posted: Feb 18, 2021
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Acne Vulgaris; Adapalene
• Additional relevant MeSH terms: Acne Vulgaris; Adapalene

Study Results

Participant Flow

Recruitment Details	Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008
Pre-assignment Detail	Washout requirements: 2 weeks for systemic anti-inflammatory drugs, 4 weeks for oral antibiotics, 2 months for inhaled/nasal steroids and 6 months for hormonal contraceptives/therapies.

Arm/Group Title	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks
Period Title: Overall Study
STARTED	535	531
COMPLETED	475	462
NOT COMPLETED	60	69

Baseline Characteristics

Arm/Group Title	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%	Total
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks	Total of all reporting groups
Overall Participants	535	531	1066
Age (Count of Participants)
<=18 years	338 63.2%	336 63.3%	674 63.2%
Between 18 and 65 years	197 36.8%	195 36.7%	392 36.8%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.1 (6.8)	19.2 (7.3)	19.15 (7.05)
Sex: Female, Male (Count of Participants)
Female	300 56.1%	272 51.2%	572 53.7%
Male	235 43.9%	259 48.8%	494 46.3%
Region of Enrollment (participants) [Number]
United States	487 91%	484 91.1%	971 91.1%
Canada	48 9%	47 8.9%	95 8.9%

Outcome Measures

1. Primary Outcome

Title	Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Description	Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
Time Frame	From Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks
Measure Participants	535	531
Number [Percentage of Participants]	24.1 4.5%	16.4 3.1%

2. Primary Outcome

Title	Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks
Measure Participants	535	531
Least Squares Mean (Standard Error) [Absolute Change in Total Lesion Count]	32.5 (1.0)	23.3 (1.0)

3. Secondary Outcome

Title	Mean Percent Change in Total Lesion Count From Baseline to Week 12
Description	Percent change in lesion count from baseline to week 12
Time Frame	From Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks
Measure Participants	535	531
Total lesion count	-44.6 (33.2)	-32.8 (34.1)
Inflammatory	-46.0 (36.8)	-36.9 (40.7)
Non-Inflammatory	-43.1 (40.9)	-30.2 (40.5)

4. Primary Outcome

Title	Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks
Measure Participants	535	531
Least Squares Mean (Standard Error) [Absolute Change in Infl Lesion count]	13.0 (0.5)	10.4 (0.5)

5. Primary Outcome

Title	Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks
Measure Participants	535	531
Least Squares Mean (Standard Error) [Absolute Change in Non-Infl Lesion]	19.5 (0.8)	12.9 (0.8)

Adverse Events

Arm/Group Title	Adapalene Lotion 0.1%		Adapalene Lotion Vehicle 0%
Arm/Group Description	once a day for 12 weeks		once a day for 12 weeks
All Cause Mortality
	Adapalene Lotion 0.1%		Adapalene Lotion Vehicle 0%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Adapalene Lotion 0.1%		Adapalene Lotion Vehicle 0%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/535 (0%)		0/531 (0%)
Other (Not Including Serious) Adverse Events
	Adapalene Lotion 0.1%		Adapalene Lotion Vehicle 0%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/535 (6%)		11/531 (2.1%)
Skin and subcutaneous tissue disorders
Dry Skin	32/535 (6%)	33	11/531 (2.1%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

disclosure restriction varies per institutional request/agreement