Status:
COMPLETED
Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
Brief Summary
Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.
Detailed Description
Multi-center, double-blind, randomized, parallel group study enrolling male or female subjects with acne vulgaris. Screening will take place within 14 days prior to Baseline. At the Baseline visit, a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00660985
Start Date
May 1 2008
End Date
November 1 2008
Last Update
February 18 2021
Active Locations (2)
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1
DermResearch, Inc.
Austin, Texas, United States, 78759
2
J&S Studies, Inc.
College Station, Texas, United States, 77845