NCT01522456

Brief Summary

To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 23, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

August 18, 2015

Completed
Last Updated

August 1, 2022

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

January 23, 2012

Results QC Date

March 11, 2013

Last Update Submit

July 28, 2022

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (4)

  • Worst Postbaseline Tolerability (Erythema)

    Worst postbaseline tolerability assessment for erythema.

    Day 1 - Day 22

  • Worst Postbaseline Tolerability (Scaling)

    Worst postbaseline assessment for scaling.

    Day 1 - Day 22

  • Worst Postbaseline Tolerability (Dryness)

    Worst postbaseline tolerability assessments for dryness.

    Day 1 - Day 22

  • Worst Postbaseline Tolerability (Stinging/Burning)

    Worst postbaseline tolerability assessments for stinging/burning

    Day 1 - Day 22

Secondary Outcomes (9)

  • Tolerability at Day 22 (Erythema)

    Day 22

  • Tolerability at Day 22 (Dryness)

    Day 22

  • Tolerability at Day 22 (Scaling)

    Day 22

  • Tolerability at Day 22 (Stinging/Burning)

    Day 22

  • Cumulative Tolerability (Erythema)

    Day 1 - Day 22

  • +4 more secondary outcomes

Other Outcomes (3)

  • User Preference Survey (Investigator)

    Day 5, day 12, day 19, and day 22

  • User Preference Survey (Subjects)

    Day 5, day 12, day 19, and day 22

  • Overall Tolerability Preference Survey

    Day 22

Study Arms (2)

Epiduo Gel

ACTIVE COMPARATOR

Adapalene 0.1% and benzoyl peroxide 2.5% gel

Drug: Epiduo Gel

Retin-A Micro Microsphere 0.1%

ACTIVE COMPARATOR

Tretinoin gel, 0.1%

Drug: Retin-A Micro Microsphere 0.1%

Interventions

Epiduo GelDRUG

Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.

Epiduo Gel
Retin-A Micro Microsphere 0.1%DRUG

Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.

Retin-A Micro Microsphere 0.1%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects of any race
  • Subjects 18 years or older
  • Subjects with acne vulgaris

You may not qualify if:

  • Subjects with an allergy to a component of the study drugs (refer to the package inserts for Epiduo Gel and Retin-A Micro 0.1%)
  • Subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids)
  • Subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids)
  • Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area
  • Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephens and Associates

Dallas, Texas, 75006, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title
Elizabeth M. Nieman, Associate Medical Information Specialist
Organization
Galderma Laboratories, L.P.
elizabeth.nieman@galderma.com
817-961-5130

Study Officials

  • Ronald Gottschalk, MD

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 31, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 1, 2022

Results First Posted

August 18, 2015

Record last verified: 2015-08

Locations

US(1)