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| Sponsor: | Allergan |
|---|---|
| Information provided by: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00151541 |
Purpose
The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Dapsone Topical Gel + adapalene gel 0.1% Drug: Dapsone Topical Gel + benzoyl peroxide gel 4% Drug: Dapsone Topical Gel + vehicle control |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Double-blind, Multi-dose Study to Evaluate the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG 5%) When Co-administered With Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4% in the Treatment of Acne Vulgaris. |
| Enrollment: | 301 |
| Study Start Date: | February 2005 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
This is a 3 arm, 12-week, randomized, double-blind, multicenter study comparing safety and efficacy of DTG 5% twice daily plus vehicle control once daily vs. DTG 5% twice daily plus adapalene gel 0.1% once daily vs. DTG 5% twice daily plus 4% benzoyl peroxide gel once daily in subjects with acne vulgaris. Approximately 300 male and female subjects, 12 years of age and older, with acne vulgaris and > 20 inflammatory lesions (papules and/or pustules) and > 20 non-inflammatory lesions (comedones) above the mandibular line at Baseline will be enrolled. Follow-up visits will occur at Week 2, 4, 8 and 12. Global Acne Assessments, Lesion Counts and Local Adverse Reaction Assessments will be conducted at each visit. A physical exam will be done at Baseline and Week 12. Plasma Dapsone Level samples will be drawn at Baseline, Week 2 and Week 12/ET for dapsone plasma level assessments. Adverse events and concomitant medications will be assessed throughout the study.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study subjects will be considered for participation based upon medical history and findings from the pre-study interview and examination. They will be enrolled according to the following conditions:
A female subject of childbearing potential must not be pregnant or nursing. All female subjects must be practicing an effective method of birth control as determined by the Investigator. Any female who is not sexually active must agree to begin using an effective method of birth control, excluding hormonal birth control, if she becomes sexually active during the study.
A female subject using hormonal birth control must have been on a stable dose for 3 months prior to Baseline.
Note: A surgically sterilized partner is not an acceptable method of birth control.
A urine pregnancy test will be required of all female subjects, 60 years of age and younger prior to treatment. If the subject can provide documentation of surgical sterilization, at the baseline visit, a pregnancy test is not required.
Negative test results must be obtained prior to randomization.
Exclusion Criteria:
MEDICATIONS EXCLUDED IN THE ADMISSION CRITERIA WILL NOT BE PERMITTED DURING THE STUDY.
Subjects who meet any of the following criteria will be excluded from study entry:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00151541 History of Changes |
| Other Study ID Numbers: | DAP0407 |
| Study First Received: | September 7, 2005 |
| Last Updated: | May 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Acne Vulgaris Acne Dermatology Dapsone Dapsone Topical Gel |
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Dapsone Dermatologic Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |