- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00660985
Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%
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
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78759
- Dermresearch, Inc.
-
College Station, Texas, United States, 77845
- J&S Studies, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Differin® Gel, 0.3%
Gel, 0.3%, 2g, once daily for 30 days
|
Gel, 0.3%, 2g, once daily for 30 days
Gel, 0.1%, 2g, once daily for 30 days
|
Active Comparator: Differin® Gel, 0.1%
Gel, 0.1%, 2g, once daily for 30 days
|
Gel, 0.3%, 2g, once daily for 30 days
Gel, 0.1%, 2g, once daily for 30 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax (ng/mL) at Day 1
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)
|
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
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)
|
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
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose)
|
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
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)
|
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
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)
|
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
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)
|
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))
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)
|
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))
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)
|
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))
Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)
|
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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Dermatologic Agents
- Adapalene
Other Study ID Numbers
- RD.06.SPR.18115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
-
Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Nexgen Dermatologics, Inc.Unknown
-
Rejuva Medical AestheticsHealMD, LLCNot yet recruitingAcne Vulgaris (Disorder)United States
-
InMode MD Ltd.Active, not recruitingInflammatory Acne VulgarisUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingModerate to Severe Acne VulgarisChina
-
PollogenLumenis Be Ltd.RecruitingModerate to Severe Acne VulgarisUnited States
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
Clinical Trials on Adapalene
-
Mahidol UniversityCompleted
-
Galderma R&DCompleted
-
Galderma R&DCompletedAcne VulgarisAustralia, Belgium, Brazil, France, Germany, Italy, Mexico, Poland, Sweden
-
Galderma R&DCompletedSkin ManifestationsUnited States
-
Wake Forest UniversityGalderma R&DCompleted
-
Galderma R&DCompletedAcne VulgarisUnited States, Canada
-
Taro Pharmaceuticals USACompleted
-
Galderma R&DCompleted
-
Galderma R&DCompletedAcne VulgarisUnited States, Canada