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Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

This study has been withdrawn prior to enrollment.
(Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01425320
First received: August 26, 2011
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.


Condition Intervention Phase
Acne Vulgaris
 Drug: Fixed Combination dapsone/adapalene Formulation A Gel
Drug: Fixed Combination dapsone/adapalene Formulation B Gel
Drug: dapsone 5% gel
Drug: adapalene 0.3% gel
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Plasma Levels of Dapsone [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Plasma Levels of Dapsone [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Plasma Levels of Adapalene [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Plasma Levels of Adapalene [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local Dermal Tolerability Rating Using a 4-Point Scale [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fixed Combination dapsone/adapalene Formulation A Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
 Drug: Fixed Combination dapsone/adapalene Formulation A Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
Experimental: Fixed Combination dapsone/adapalene Formulation B Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
 Drug: Fixed Combination dapsone/adapalene Formulation B Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
Active Comparator: dapsone 5% gel (ACZONE®)
Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
 Drug: dapsone 5% gel
Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
Other Name: ACZONE®
Active Comparator: adapalene 0.3% gel (Differin®)
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
 Drug: adapalene 0.3% gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
Other Name: Differin®

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate acne on the face
  • Willing to avoid swimming during the study
  • Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study
  • Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study

Exclusion Criteria:

  • Severe cystic acne
  • Use of topical or oral retinoids within 4 weeks
  • Use of isotretinoin within 3 months
  • Use of dapsone or adapalene within 3 months
  • Anticipated need to engage in activities/exercise that would cause profuse sweating
  • Donated blood or equivalent blood loss within 90 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425320

Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01425320     History of Changes
Other Study ID Numbers: 225678-003
Study First Received: August 26, 2011
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Dapsone
Adapalene
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013