Recent Updates
Recently added Catalysts

Dapsone 5%

Phase 3

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

Dapsone 5% target and mechanism

ModalitySmall molecule

Also known as Dapsone 5% Gel

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment301

FDA Designations

No designations recorded

Dapsone 5% clinical trials

Dapsone 5% · 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 VulgarisUnlock trial analytics

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.
Unlock Study Endpoints

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 -
Unlock Study Design Details

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...

Unlock Eligibility Criteria

Frequently asked questions about Dapsone 5%

What is Dapsone 5% used for?

Dapsone 5% is a topical small molecule treatment being developed for acne vulgaris. It is applied to the skin and has been studied in a Phase 3 trial in patients aged 12 years and older. The trial evaluated its use both as a standalone gel and in combination with adapalene gel 0.1% or benzoyl peroxide gel 4%.

Who makes Dapsone 5%?

Dapsone 5% is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the company responsible for the clinical development of this topical acne treatment.

What phase is Dapsone 5% in?

Dapsone 5% is in Phase 3 clinical development for acne vulgaris. One Phase 3 trial has been completed, and no active trials are currently listed. The completed trial enrolled 301 participants and was randomized and double-blind.

What clinical trials is Dapsone 5% in?

Dapsone 5% has been studied in one completed Phase 3 trial, NCT00151541. This trial compared 5% dapsone topical gel twice daily in combination with a once-daily vehicle control, adapalene gel 0.1%, or benzoyl peroxide gel 4% in 301 participants with acne vulgaris.