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Dapsone+ adapalene 0.1%

Phase 3

Acne Vulgaris | Small molecule | Dermatology |AbbVie Inc.|Last Updated: May 30, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment301

FDA Designations

No designations recorded

Clinical trial landscape

Dapsone+ adapalene 0.1% · 1 trial · 1 indication

Phase 3 1
NCT00151541A Phase 3 Study 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%Acne Vulgaris
COMPLETED301 Analytics
PHASE3COMPLETED
A Phase 3 Study 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%
Acne Vulgaris
NCT00151541301
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Study Endpoints

Primary Endpoints

The primary efficacy endpoint will be mean percent reduction in inflammatory lesion counts.

Secondary Endpoints

Additional efficacy endpoints will be the mean percent reduction from Baseline in non-inflammatory and total lesion counts, as well as the proportion of subjects who achieve success (none/minimal) on a 5-point Global Acne Assessment Score.
Safety endpoints will include treatment-emergent and treatment related adverse events. An additional safety endpoint will be the local adverse reaction assessment.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Dapsone Topical Gel + adapalene gel 0.1%DRUG -
Dapsone Topical Gel + benzoyl peroxide gel 4%DRUG -
Dapsone Topical Gel + vehicle controlDRUG -
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo

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: 1. Each subject or parent/guardian will read and sign the informed assent and/o...

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Frequently asked questions about Dapsone+ adapalene 0.1%

What is Dapsone+ adapalene 0.1% used for?

Dapsone+ adapalene 0.1% is a combination therapy being studied for the treatment of acne vulgaris. It is a small molecule product in the dermatology therapeutic area. The combination is currently in Phase 3 clinical development, meaning it is investigational and not yet approved for use.

Who makes Dapsone+ adapalene 0.1%?

Dapsone+ adapalene 0.1% is being developed by AbbVie Inc., which trades under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for acne vulgaris.

What phase is Dapsone+ adapalene 0.1% in?

Dapsone+ adapalene 0.1% is in Phase 3 clinical development. It is an investigational combination therapy for acne vulgaris and has not been approved by regulatory authorities. One Phase 3 trial has been completed as part of its development program.

What clinical trials is Dapsone+ adapalene 0.1% in?

Dapsone+ adapalene 0.1% has been studied in one completed Phase 3 clinical trial, identified as NCT00151541. This randomized, double-blind study enrolled 301 participants aged 12 years and older with acne vulgaris. The trial compared the combination of 5% dapsone topical gel with adapalene gel 0.1% or benzoyl peroxide gel 4%.

Is Dapsone+ adapalene 0.1% the same as dapsone and adapalene used separately?

Dapsone+ adapalene 0.1% refers to a combination of dapsone and adapalene 0.1% being studied together. In the clinical trial NCT00151541, 5% dapsone topical gel was used in combination with adapalene gel 0.1% or benzoyl peroxide gel 4%, suggesting the combination is being evaluated as a potential treatment for acne vulgaris.