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

Completed · Phase 4

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT00660985

Run by

Galderma R&D

People needed

51

Starts

2008-05-01

Expected to finish

2008-11-01

Last updated by the study team

2021-02-18

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• DermResearch, Inc. — Austin, Texas, United States
• J&S Studies, Inc. — College Station, Texas, United States

Full record on ClinicalTrials.gov

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