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Acne VulgarisPhase 4NCT01522456

Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel

A Phase 4 study testing Epiduo Gel and Retin-A Micro Microsphere 0.1% in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acne Vulgaris
What is being tested?
Epiduo Gel and Retin-A Micro Microsphere 0.1%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
Apr 2012to May 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stephens and Associates

    Dallas, Texas, 75006

Other trials in United States

About this study

Official title: Split-face Tolerability Comparison Between Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Versus Retin-A Micro® (Tretinoin Gel) Microsphere, 0.1% in Subjects With Acne Vulgaris

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.

Read the detailed description

Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.

Conditions
Acne Vulgaris
Being tested
Epiduo Gel, Retin-A Micro Microsphere 0.1%
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epiduo GelDrug

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

Study groups in NCT01522456
Study groupRoleWhat they receive
Epiduo GelActive comparatorAdapalene 0.1% and benzoyl peroxide 2.5% gel
Receives: Drug: Epiduo Gel
Retin-A Micro Microsphere 0.1%Active comparatorTretinoin gel, 0.1%
Receives: Drug: Retin-A Micro Microsphere 0.1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Worst Postbaseline Tolerability (Erythema)

    Worst postbaseline tolerability assessment for erythema.

    Measured: Day 1 - Day 22

  2. Worst Postbaseline Tolerability (Scaling)

    Worst postbaseline assessment for scaling.

    Measured: Day 1 - Day 22

  3. Worst Postbaseline Tolerability (Dryness)

    Worst postbaseline tolerability assessments for dryness.

    Measured: Day 1 - Day 22

  4. Worst Postbaseline Tolerability (Stinging/Burning)

    Worst postbaseline tolerability assessments for stinging/burning

    Measured: Day 1 - Day 22

Secondary outcomes (9)

  1. Tolerability at Day 22 (Erythema)

    Tolerability assessments at day 22 for erythema

    Measured: Day 22

  2. Tolerability at Day 22 (Dryness)

    Tolerability assessments at day 22 for dryness

    Measured: Day 22

  3. Tolerability at Day 22 (Scaling)

    Tolerability assessments at day 22 for scaling

    Measured: Day 22

  4. Tolerability at Day 22 (Stinging/Burning)

    Tolerability assessments at day 22 for stinging/burning

    Measured: Day 22

  5. Cumulative Tolerability (Erythema)

    Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

    Measured: Day 1 - Day 22

  6. Cumulative Tolerability (Scaling)

    Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

    Measured: Day 1 - Day 22

  7. Cumulative Tolerability (Dryness)

    Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

    Measured: Day 1 - Day 22

  8. Cumulative Tolerability (Stinging/Burning)

    Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

    Measured: Day 1 - Day 22

  9. Cumulative Tolerability (Combined)

    Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.

    Measured: Day 1 - Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01522456
Sponsor's protocol ID
US10201
Status last verified
Aug 2015
First submitted
23 Jan 2012
Last updated
1 Aug 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epiduo Gel and Retin-A Micro Microsphere 0.1% in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Worst Postbaseline Tolerability (Erythema) (time frame: Day 1 - Day 22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01522456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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