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An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

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.
 
ClinicalTrials.gov Identifier: NCT01785836
Recruitment Status : Withdrawn (Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.)
First Posted : February 7, 2013
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Dapsone Formulation A Drug: Dapsone Formulation B Drug: Dapsone Formulation C Drug: Dapsone 5% Gel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

Arm Intervention/treatment
Experimental: Dapsone Formulation A
Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Drug: Dapsone Formulation A
Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Experimental: Dapsone Formulation B
Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Drug: Dapsone Formulation B
Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Experimental: Dapsone Formulation C
Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Drug: Dapsone Formulation C
Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Active Comparator: Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Drug: Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Other Name: ACZONE®




Primary Outcome Measures :
  1. Change from Baseline in Inflammatory Lesion Count [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline in Non-Inflammatory Lesion Count [ Time Frame: Baseline, Week 12 ]
  2. Change from Baseline in Total Lesion Count [ Time Frame: Baseline, Week 12 ]
  3. Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1 [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in Allergan study 225678-004

Exclusion Criteria:

  • Anticipates the need for surgery or hospitalization during the study

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): NCT01785836


Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01785836    
Other Study ID Numbers: 225678-005
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Dapsone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents