Phase 4
Completed N=51
Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%
Source: ClinicalTrials.gov NCT00660985 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcomePrimary: Cmax (ng/mL) at Day 1 — 0.10; 0.02 ng/mL
Summary
Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (ng/mL) at Day 1 |
0.10; 0.02 | — |
| PRIMARY Cmax (ng/mL) at Day 15 |
0.18; 0.04 | — |
| PRIMARY Cmax (ng/mL) at Day 30 |
0.15; 0.03 | — |
| PRIMARY Tmax (hr) at Day 1 |
15; 11 | — |
| PRIMARY Tmax (hr) at Day 15 |
13; 11 | — |
| PRIMARY Tmax (hr) at Day 30 |
13; 12 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24)) |
1.54; 0.31 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24)) |
2.84; 0.50 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24)) |
2.64; 0.42 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00660985). 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.