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

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene lotion 0.1%; Drug: Adapalene Lotion Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00599521

IND 076057

RD.06.SPR.18114

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,067 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,067 participants in 2 patient groups, including a placebo group

Adapalene lotion 0.1%

Experimental group

Treatment:

Drug: Adapalene lotion 0.1%

Adapalene Lotion vehicle

Placebo Comparator group

Treatment:

Drug: Adapalene Lotion Vehicle