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

NCT00660985 | Completed Phase 4 Results

• 1 other identifier: RD.06.SPR.18115
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acne Vulgaris

Keywords

Acne vulgaris; Differin; Adapalene

Outcome Measures

Primary Outcomes (9)

• Cmax (ng/mL) at Day 1

  the observed peak drug (adapalene) concentration

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

• Cmax (ng/mL) at Day 15

  the observed peak drug (adapalene) concentration

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

• Cmax (ng/mL) at Day 30

  the observed peak drug (adapalene) concentration

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose)

• Tmax (hr) at Day 1

  the time at which Cmax occurs

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

• Tmax (hr) at Day 15

  the time at which Cmax occurs

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

• Tmax (hr) at Day 30

  the time at which Cmax occurs

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)

• Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24))

  area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24 hr (corresponding to the dosing interval)

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

• Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24))

  area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

• Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24))

  area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)

  T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)

Study Arms (2)

Differin® Gel, 0.3%

EXPERIMENTAL

Gel, 0.3%, 2g, once daily for 30 days

Drug: Adapalene

Differin® Gel, 0.1%

ACTIVE COMPARATOR

Gel, 0.1%, 2g, once daily for 30 days

Drug: Adapalene

Interventions

Adapalene DRUG

Gel, 0.3%, 2g, once daily for 30 days

Differin® Gel, 0.3%

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Michael Graeber, MD, Head of Global Clinical Project Management and US Development
• Organization: Galderma

michael.graeber@galderma.com

609-860-8201

Study Officials

• Michael Graeber, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 18, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 18, 2021
• Results First Posted: December 29, 2009

Record last verified: 2011-01

Locations

US (2)