Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Adapalene

Criteria

Inclusion Criteria:

• Male or female 18 to 35 years of age

• Clinical diagnosis of acne vulgaris

• Minimum of 20 Inflammatory

• Minimum of 20 Non-inflammatory lesions

• The subject has a body weight between 45 and 100 kg, and a Body Mass Index (BMI) between 18 and 30Kg/m2

Exclusion Criteria:

• More than 1 nodule or any cyst on the face (excluding the nose)

• Acne conglobata, acne fulminans, secondary acne or severe acne

• Underlying diseases or other dermatological conditions that require the use of interfering topical or systemic therapy

• Pregnant or nursing or planning a pregnancy

• Surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the drug

• Known allergies to any of the ingredients of the study medication

• History of alcohol or drug abuse or positive test results for any drug abuse

• Positive test results for hepatitis B surface antigen (HBs-Ag), hepatitis C virus (HCV) or human immunodeficiency virus antibodies (HIV Ab)

• Use of prohibited medications prior to the study unless appropriate washout period is documented