search
Back to results

A Study of Acne Treatment in Children Ages 9 to 11

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Retin-A Micro 0.04% facial acne treatment
Vehicle control
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, irritation, objective sensory methods

Eligibility Criteria

9 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Encino Research Center
  • Children's Hospital and Health Center
  • Department of Dermatology, University of Miami
  • Department of Dermatology, Northwestern University
  • Dermatology Associates
  • UMDNJ-RWJ Medical School
  • SUNY Downstate Medical Center Department of Dermatology
  • Dermatology Research Associates
  • Skin Study Center
  • Yardley Dermatology Associates
  • Omega Medical Research
  • University of Texas Medical School at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Retin-A Micro

Vehicle Control

Arm Description

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

Color matched facial gel vehicle control used once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
May 20, 2009
Last Updated
February 14, 2012
Sponsor
Bausch Health Americas, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00907335
Brief Title
A Study of Acne Treatment in Children Ages 9 to 11
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne, irritation, objective sensory methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retin-A Micro
Arm Type
Experimental
Arm Description
Retin-A Micro 0.04% facial acne treatment used once daily
Arm Title
Vehicle Control
Arm Type
Placebo Comparator
Arm Description
Color matched facial gel vehicle control used once daily
Intervention Type
Drug
Intervention Name(s)
Retin-A Micro 0.04% facial acne treatment
Other Intervention Name(s)
facial acne treatment
Intervention Description
Retin-A Micro 0.04% facial acne treatment used once daily
Intervention Type
Drug
Intervention Name(s)
Vehicle control
Other Intervention Name(s)
placebo
Intervention Description
Color-matched facial gel vehicle control used once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Total Non-inflammatory Lesion Count
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Lesion Counts
Description
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.
Time Frame
Baseline to Week 12
Title
Measurement of Success 1
Description
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.
Time Frame
Week 12
Title
Measurement of Success 2
Description
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.
Time Frame
Week 12
Title
Measurement of Success 3
Description
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.
Time Frame
Week 12
Title
Global Assessment
Description
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.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Rossi, MD
Organizational Affiliation
Johnson & Johnson Consumer and Personal Products Worldwide
Official's Role
Study Director
Facility Information:
Facility Name
Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Children's Hospital and Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Department of Dermatology, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Department of Dermatology, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dermatology Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
UMDNJ-RWJ Medical School
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
SUNY Downstate Medical Center Department of Dermatology
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Dermatology Research Associates
City
Cincinnatti
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
Skin Study Center
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Yardley Dermatology Associates
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22712470
Citation
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.
Results Reference
derived
Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Description
FDA's Drug Finder

Learn more about this trial

A Study of Acne Treatment in Children Ages 9 to 11

We'll reach out to this number within 24 hrs