NCT03132194

Brief Summary

To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,125

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

March 16, 2017

Last Update Submit

May 3, 2017

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

  • Change in inflammatory lesion counts

    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

    12 weeks

  • Change in non-inflammatory lesion counts

    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

    12 weeks

Secondary Outcomes (1)

  • Clinical response of success

    12 weeks

Study Arms (3)

DPSG 7.5%

EXPERIMENTAL

DPSG 7.5% (Taro Pharmaceuticals USA) Topical, twice daily on the face for 84 days.

Drug: DPSG 7.5%

Vehicle Gel

PLACEBO COMPARATOR

Placebo product (Taro Pharmaceuticals Inc.) Topical, twice daily on the face for 84 days.

Drug: Placebo

Aczone

ACTIVE COMPARATOR

dapsone 7.5 Topical, twice daily on the face for 84 days.

Drug: Aczone

Interventions

DPSG 7.5%DRUG

topical gel

Also known as: dapsone
DPSG 7.5%
AczoneDRUG

topical gel

Also known as: dapsone
Aczone
PlaceboDRUG

topical gel

Also known as: Vehicle
Vehicle Gel

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.

You may not qualify if:

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dapsone

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic Chemicals

Study Officials

  • Catawba Research

    http://catawbaresearch.com/contact/

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 16, 2017

First Posted

April 27, 2017

Study Start

August 8, 2016

Primary Completion

January 16, 2017

Study Completion

January 30, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share