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

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00660985

Purpose

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

Condition	Intervention	Phase
Acne Vulgaris	Drug: Adapalene	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: Acne

Drug Information available for: Adapalene

U.S. FDA Resources

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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 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 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 ]

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
Differin® Gel, 0.3%: Experimental Gel, 0.3%, 2g, once daily for 30 days	Drug: Adapalene Gel, 0.3%, 2g, once daily for 30 days
Differin® Gel, 0.1%: Active Comparator 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

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:	Galderma R&D ( Michael Graeber, MD, Head of US Development: )
Study ID Numbers:	RD.06.SPR.18115
Study First Received:	April 15, 2008
Results First Received:	October 15, 2009
Last Updated:	January 7, 2010
ClinicalTrials.gov Identifier:	NCT00660985 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Galderma:

Acne vulgaris
Differin
Adapalene

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Physiological Effects of Drugs
Sebaceous Gland Diseases
Adapalene
Acne Vulgaris
Pharmacologic Actions
Acneiform Eruptions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010