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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01425320
First Posted: August 30, 2011
Last Update Posted: November 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Plasma Levels of Dapsone [ Time Frame: Day 1 ]
  • Plasma Levels of Dapsone [ Time Frame: Day 14 ]
  • Plasma Levels of Adapalene [ Time Frame: Day 1 ]
  • Plasma Levels of Adapalene [ Time Frame: Day 14 ]

Secondary Outcome Measures:
  • Local Dermal Tolerability Rating Using a 4-Point Scale [ Time Frame: Day 14 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425320


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01425320     History of Changes
Other Study ID Numbers: 225678-003
First Submitted: August 26, 2011
First Posted: August 30, 2011
Last Update Posted: November 19, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Dapsone
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
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents