Recent Updates
Recently added Catalysts

Dapsone Formulation A

Phase 1

Acne Vulgaris | Small molecule | Dermatology |AbbVie Inc.|Last Updated: Apr 24, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

Dapsone Formulation A · 1 trial · 1 indication

Phase 1 1
NCT01773122Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne VulgarisAcne Vulgaris
COMPLETED77 Analytics
PHASE1COMPLETED
Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
Acne VulgarisUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Plasma Level (Cmax) of Dapsone
Day 28

Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.

Secondary Endpoints

Maximum Plasma Level (Cmax) of Dapsone Metabolites
Day 28
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Dapsone Formulation AEXPERIMENTALDapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation BEXPERIMENTALDapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation CEXPERIMENTALDapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone 5% GelACTIVE_COMPARATORDapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.

Interventions

NameTypeDescription
Dapsone Formulation ADRUGDapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation BDRUGDapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation CDRUGDapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone 5% GelDRUGDapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Unlock Study Design Details

Eligibility Criteria

Age Range16 Years to 35 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of acne vulgaris * Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study * If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Dapsone Formulation A

What is Dapsone Formulation A used for?

Dapsone Formulation A is an investigational small molecule being developed for the treatment of acne vulgaris, a common skin condition characterized by pimples and inflammation. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Dapsone Formulation A?

Dapsone Formulation A is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical research to evaluate the safety and pharmacokinetics of this investigational drug.

What phase is Dapsone Formulation A in?

Dapsone Formulation A is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 1 trial has been completed, and the drug remains under evaluation for the treatment of acne vulgaris.

What clinical trials is Dapsone Formulation A in?

Dapsone Formulation A has been studied in one completed Phase 1 clinical trial with the identifier NCT01773122, titled "Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris." The trial enrolled 77 participants in the United States and was randomized, double-blind, and active-controlled.

Is Dapsone Formulation A the same as dapsone?

Dapsone Formulation A is a specific formulation of dapsone, a small molecule drug. While dapsone itself is a known medication, this particular formulation is being investigated as a new treatment for acne vulgaris and is currently in Phase 1 clinical development.