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Acne VulgarisPhase 2NCT00907335

A Study of Acne Treatment in Children Ages 9 to 11

A Phase 2 study testing Retin-A Micro 0.04% facial acne treatment in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 12 sites 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

A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious. Read more about this study

Who is it for?
Ages 9 to 11 years
Conditions the study is for
Acne Vulgaris
What is being tested?
Retin-A Micro 0.04% facial acne treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
12 sitesUnited States
Study dates
Feb 2009to Dec 2009
Phase
Phase 2
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 9 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Males and non-pregnant, non-nursing females, 9 to 11 years, with facial pediatric acne vulgaris
  • Minimum of 20 non-inflammatory lesions (open and closed comedones)
  • Minimum of 30 total facial lesions (sum of inflammatory and non-inflammatory)
  • Must have at least a rating of grade 3 on the Investigator Global Assessment Scale for acne severity (IGA #1) at baseline

Who cannot join

  • Known sensitivity to any of the ingredients in the study medication;
  • Any nodulocystic acne lesions
  • Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study
  • Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study
  • Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
  • Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study
Show all 14Show fewer
  • Use of an experimental drug or device within 60 days prior to study start;
  • Use of hormonal therapy within 3 months prior to study start
  • History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
  • Any significant medical conditions that could confound the interpretation of the study
  • History of/or current facial skin cancer
  • Inability to refrain from use of all facial products other than those supplied by the study, while participating in the study
  • No use of tanning booths, sun lamps, etc.
  • Subject is a family member of the employee or the investigator

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • SUNY Downstate Medical Center Department of Dermatology

    Brooklyn, New York, 11203

  • Skin Study Center

    Broomall, Pennsylvania, 19008

  • Department of Dermatology, Northwestern University

    Chicago, Illinois, 60611

  • Dermatology Research Associates

    Cincinnatti, Ohio, 45230

  • Encino Research Center

    Encino, California, 91436

  • University of Texas Medical School at Houston

    Houston, Texas, 77030

  • Dermatology Associates

    Louisville, Kentucky, 40202

  • Department of Dermatology, University of Miami

    Miami, Florida, 33136

  • Children's Hospital and Health Center

    San Diego, California, 92123

  • UMDNJ-RWJ Medical School

    Somerset, New Jersey, 08873

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Yardley Dermatology Associates

    Yardley, Pennsylvania, 19067

Other trials in United States

About this study

Official title: A Multi-Center, Double Blind, Vehicle Controlled, Study of Retin-A Micro 0.04% in the Treatment of Pediatric Acne Vulgaris in Children, Ages 9 to 11 Years of Age

A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.

Read the detailed description

Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled in this randomized, double blind, multi-center study.

Following satisfaction of entry criteria and screening procedures, subjects will receive either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the 12-week treatment period. Subjects will be monitored for safety throughout the study and for signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at study completion, week 12.

Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment of Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be taken at Baseline and weeks 2, 4, 8 and 12.

Conditions
Acne Vulgaris
Being tested
Retin-A Micro 0.04% facial acne treatment, Vehicle control
Keywords
acne, irritation, objective sensory methods
Medical subject headings
Acne Vulgaris

What participants receive

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

  • Retin-A Micro 0.04% facial acne treatmentDrug

    Also called facial acne treatment

    Retin-A Micro 0.04% facial acne treatment used once daily

  • Vehicle controlDrug

    Also called placebo

    Color-matched facial gel vehicle control used once daily

Study groups in NCT00907335
Study groupRoleWhat they receive
Retin-A MicroExperimentalRetin-A Micro 0.04% facial acne treatment used once daily
Receives: Drug: Retin-A Micro 0.04% facial acne treatment
Vehicle ControlPlacebo comparatorColor matched facial gel vehicle control used once daily
Receives: Drug: Vehicle control

What is being measured

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

  1. Change From Baseline in Total Non-inflammatory Lesion Count

    Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.

    Measured: Baseline to Week 12

Secondary outcomes (5)

  1. Change From Baseline in Lesion Counts

    Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.

    Measured: Baseline to Week 12

  2. Measurement of Success 1

    Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.

    Measured: Week 12

  3. Measurement of Success 2

    Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.

    Measured: Week 12

  4. Measurement of Success 3

    Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of "Excellent" or "Good" scores.

    Measured: Week 12

  5. Global Assessment

    Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.

    Measured: Baseline to Week 12

Timeline

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

  1. First posted22 May 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2009
  4. Study completionDec 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00907335
Sponsor's protocol ID
CA-P-6397
Status last verified
Feb 2012
First submitted
20 May 2009
Last updated
15 Feb 2012
Data monitoring committee
No

Publications

  • Eichenfield LF, Hebert AA, Schachner L, Paller AS, Rossi AB, Lucky AW. Tretinoin microsphere gel 0.04% pump for treating acne vulgaris in preadolescents: a randomized, controlled study. Pediatr Dermatol. 2012 Sep-Oct;29(5):598-604. doi: 10.1111/j.1525-1470.2012.01811.x. Epub 2012 Jun 19.

    PubMed 22712470

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retin-A Micro 0.04% facial acne treatment in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 12 sites 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 4 inclusion and 14 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Mar 2011). 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?

Change From Baseline in Total Non-inflammatory Lesion Count (time frame: Baseline to Week 12). 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 NCT00907335, which also lists 1 linked publication.

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 15 Feb 2012.

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