NCT02709902

Brief Summary

Bioequivalence with Clinical Endpoints.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2015

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

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

March 8, 2016

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

    Week 12

  • Change in non-inflammatory lesion counts

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

    Week 12

Secondary Outcomes (1)

  • Clinical response of success

    Week 12

Study Arms (3)

Adapalene/BP gel, 0.3%/2.5%

EXPERIMENTAL

Topical, once daily, for 84 days.

Drug: Adapalene/BP gel, 0.3%/2.5%

EPIDUO® FORTE

ACTIVE COMPARATOR

Topical, once daily, for 84 days.

Drug: EPIDUO® FORTE

Placebo

PLACEBO COMPARATOR

Topical, once daily, for 84 days.

Drug: Placebo

Interventions

Adapalene/BP gel, 0.3%/2.5%DRUG

Gel

Also known as: Adapalene, benzoyl peroxide
Adapalene/BP gel, 0.3%/2.5%
EPIDUO® FORTEDRUG

Gel

Also known as: Adapalene, benzoyl peroxide
EPIDUO® FORTE
PlaceboDRUG

Gel

Also known as: Vehicle
Placebo

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
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.

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

Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoyl PeroxideBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAdapaleneNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

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

March 8, 2016

First Posted

March 16, 2016

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share