Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
This study has been completed.
Sponsor:
Galderma
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00599521
First received: January 11, 2008
Last updated: March 21, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Adapalene lotion 0.1% Drug: Adapalene Lotion Vehicle |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Galderma:
Primary Outcome Measures:
- Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]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.
- Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
- Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
- Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to 12 weeks ] [ Designated as safety issue: No ]Percent change in lesion count from baseline to week 12
| Enrollment: | 1067 |
| Study Start Date: | November 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599521
Show 34 Study Locations
Show 34 Study LocationsSponsors and Collaborators
Galderma
More Information
No publications provided
| Responsible Party: | Marie Ciardella Clinical Trials.gov Administrator, Galderma Laboratories, Inc |
| ClinicalTrials.gov Identifier: | NCT00599521 History of Changes |
| Other Study ID Numbers: | RD.06.SPR.18114, IND 076057 |
| Study First Received: | January 11, 2008 |
| Results First Received: | April 16, 2010 |
| Last Updated: | March 21, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Galderma:
|
Acne Vulgaris Adapalene |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013