Phase 3 Completed N=1,066 Randomized Quadruple-blind Treatment

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

Acne vulgaris

Source: ClinicalTrials.gov NCT00599521 ↗

Enrolled (actual)

1,066

Serious AEs

0.0%

Results posted

Apr 2011

Primary outcomePrimary: Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 — 24.1; 16.4 Percentage of Participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12	24.1; 16.4	—
PRIMARY Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12	32.5; 23.3	—
PRIMARY Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12	13.0; 10.4	—
PRIMARY Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12	19.5; 12.9	—
SECONDARY Mean Percent Change in Total Lesion Count From Baseline to Week 12	-44.6; -32.8; -46.0; -36.9; -43.1; -30.2	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00599521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.