NCT02929719

Brief Summary

Therapeutic equivalence and safety study

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,134

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Typical duration 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

April 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

October 8, 2016

Last Update Submit

May 3, 2017

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

  • Change in inflammatory lesion count

    baseline to week 12 (study day 84)

  • Change in non-inflammatory lesion count

    baseline to week 12 (study day 84)

Study Arms (3)

Test Gel 5%

EXPERIMENTAL

Topical, twice daily on the face for 84 days.

Drug: Test.

ACZONE Gel 5%

ACTIVE COMPARATOR

Topical, twice daily on the face for 84 days

Drug: Aczone Gel 5%

Placebo Gel

PLACEBO COMPARATOR

Topical, twice daily on the face for 84 days

Drug: Placebo

Interventions

Test.DRUG

gel

Also known as: dapsone
Test Gel 5%
Aczone Gel 5%DRUG

gel

Also known as: dapsone
ACZONE Gel 5%
PlaceboDRUG

gel

Also known as: Vehicle
Placebo Gel

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris
  • Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2016

First Posted

October 11, 2016

Study Start

April 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share