NCT01425320

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 19, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

August 26, 2011

Last Update Submit

November 16, 2012

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (4)

  • Plasma Levels of Dapsone

    Day 1

  • Plasma Levels of Dapsone

    Day 14

  • Plasma Levels of Adapalene

    Day 1

  • Plasma Levels of Adapalene

    Day 14

Secondary Outcomes (1)

  • Local Dermal Tolerability Rating Using a 4-Point Scale

    Day 14

Study Arms (4)

Fixed Combination dapsone/adapalene Formulation A Gel

EXPERIMENTAL

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

Fixed Combination dapsone/adapalene Formulation B Gel

EXPERIMENTAL

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

dapsone 5% gel (ACZONE®)

ACTIVE COMPARATOR

Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.

Drug: dapsone 5% gel

adapalene 0.3% gel (Differin®)

ACTIVE COMPARATOR

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Drug: adapalene 0.3% gel

Interventions

Fixed Combination dapsone/adapalene Formulation A GelDRUG

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Fixed Combination dapsone/adapalene Formulation A Gel
Fixed Combination dapsone/adapalene Formulation B GelDRUG

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Fixed Combination dapsone/adapalene Formulation B Gel
dapsone 5% gelDRUG

Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.

Also known as: ACZONE®
dapsone 5% gel (ACZONE®)
adapalene 0.3% gelDRUG

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Also known as: Differin®
adapalene 0.3% gel (Differin®)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Vulgaris

Interventions

DapsoneGelsAdapalene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsColloidsComplex MixturesDosage FormsPharmaceutical PreparationsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

August 30, 2011

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 19, 2012

Record last verified: 2012-11