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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00660985
First received: April 15, 2008
Last updated: January 19, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: Adapalene
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study to Compare the Systemic Exposure to Adapalene During Dermal Application of Either Differin® Gel, 0.3% (Adapalene 0.3%) or Differin® Gel, 0.1% (Adapalene 0.1%) for 30 Days in Subjects With Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Cmax (ng/mL) at Day 1 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ] [ Designated as safety issue: No ]
    the observed peak drug (adapalene) concentration

  • Cmax (ng/mL) at Day 15 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ] [ Designated as safety issue: No ]
    the observed peak drug (adapalene) concentration

  • Cmax (ng/mL) at Day 30 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose) ] [ Designated as safety issue: No ]
    the observed peak drug (adapalene) concentration

  • Tmax (hr) at Day 1 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ] [ Designated as safety issue: No ]
    the time at which Cmax occurs

  • Tmax (hr) at Day 15 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ] [ Designated as safety issue: No ]
    the time at which Cmax occurs

  • Tmax (hr) at Day 30 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose) ] [ Designated as safety issue: No ]
    the time at which Cmax occurs

  • Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24)) [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ] [ Designated as safety issue: No ]
    area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24 hr (corresponding to the dosing interval)

  • Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24)) [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ] [ Designated as safety issue: No ]
    area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)

  • Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24)) [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose) ] [ Designated as safety issue: No ]
    area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)


Enrollment: 51
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Differin® Gel, 0.3%
Gel, 0.3%, 2g, once daily for 30 days
Drug: Adapalene
Gel, 0.3%, 2g, once daily for 30 days
Active Comparator: Differin® Gel, 0.1%
Gel, 0.1%, 2g, once daily for 30 days
Drug: Adapalene
Gel, 0.1%, 2g, once daily for 30 days

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, and at each study day up to Day 30, a trained nurse or technician will apply 2 grams of study medication (either Differin® Gel, 0.3% or Differin® Gel, 0.1%) to the face, upper part of chest, and upper part of back of the subjects. To ensure maximal usage conditions, 2 grams study medication will be applied once daily to a total body surface area of approximately 1000 cm², which is equivalent to 2 mg/cm2.

Subjects will arrive at the clinic the night before on visit days (Day 1, Day 15 and Day 30) when PK blood samples will be drawn. Subjects will be discharged from the clinic on Day 2 and Day 16 following the 24-hour post-dose blood sample, and on Day 31 after the 36-hour post-dose blood samples.

Cutaneous safety (local tolerability assessments) will be assessed, by recording erythema, scaling, dryness, and stinging/burning sensation as separate scores on the face, upper part of the chest, and upper part of the back using a 4-point scale (0 = None to 3 = Severe). Local tolerability assessments will be performed weekly on Day 1, 8, 15, 22 and Day 30, prior application of study medication.

Efficacy will be evaluated by Inflammatory and Non-inflammatory lesion counts on the face performed at Screening, Baseline (Day 1), and on Day 30.

Subjects will have routine laboratory tests (fasting hematology, blood chemistry) performed at Screening and at Day 30 visits.

Blood samples for determination of adapalene plasma concentrations will be drawn on Day 1, Day 15, and Day 30 before the morning study medication application (pre-dose) and 1, 2, 4, 6, 8, 10, 12, 16 and 24 hours after application of study medication; and additionally after the last study medication application (Day 31, 32, 33) at 32, 36, 48 and 72 hours post-dose.

The adapalene plasma concentrations will be determined by a high performance liquid chromatography (HPLC) and fluorescence detection method.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660985

Locations
United States, Texas
DermResearch, Inc.
Austin,, Texas, United States, 78759
J&S Studies, Inc.
College Station,, Texas, United States, 77845
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma
  More Information

No publications provided

Responsible Party: Michael Graeber, MD, Head of US Development:, Galderma R&D
ClinicalTrials.gov Identifier: NCT00660985     History of Changes
Other Study ID Numbers: RD.06.SPR.18115
Study First Received: April 15, 2008
Results First Received: October 15, 2009
Last Updated: January 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
Acne vulgaris
Differin
Adapalene

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014