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A Study of Different Use Regimens Using Two Acne Treatments

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
benzoyl peroxide wash
Tretinoin gel
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

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;
  • Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);
  • Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);
  • Must have at least a rating of grade 3 on the Investigator Global severity scale 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 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;
  • If subject is taking birth control pills, she must be stabilized for at least three 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;
  • Excessive facial hair that may interfere with evaluations;
  • No use of tanning booths, sun lamps, etc.

Sites / Locations

  • Skin Care Research, Inc.
  • International Dermatology Research, Inc.
  • Gwinnett Clinical Research
  • Derm Research, PLLC
  • Minnesota Clinical Study Center
  • Academic Dermatology Associates
  • DermResearch Center of New York
  • Dermatology Research Associates
  • Yardley Dermatology Associates
  • DermResearch, Inc.
  • Education & Research Foundation, Inc.
  • Virginia Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Same time of day

Different times of day

Arm Description

5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day

5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening

Outcomes

Primary Outcome Measures

Change From Baseline in Total Facial Acne Lesion Count
Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.

Secondary Outcome Measures

Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).
Measurement of Success
Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows: 0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.

Full Information

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

Unique Protocol Identification Number
NCT00907257
Brief Title
A Study of Different Use Regimens Using Two Acne Treatments
Official Title
A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 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 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.
Detailed Description
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.

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 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Same time of day
Arm Type
Experimental
Arm Description
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Arm Title
Different times of day
Arm Type
Active Comparator
Arm Description
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Intervention Type
Drug
Intervention Name(s)
benzoyl peroxide wash
Other Intervention Name(s)
OXY Wash
Intervention Description
5% benzoyl peroxide wash
Intervention Type
Drug
Intervention Name(s)
Tretinoin gel
Other Intervention Name(s)
Retin-A Micro Pump
Intervention Description
0.04% tretinoin gel
Primary Outcome Measure Information:
Title
Change From Baseline in Total Facial Acne Lesion Count
Description
Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
Description
Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).
Time Frame
Baseline to Week 12
Title
Measurement of Success
Description
Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows: 0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris; Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules); Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones); Must have at least a rating of grade 3 on the Investigator Global severity scale 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 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; If subject is taking birth control pills, she must be stabilized for at least three 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; Excessive facial hair that may interfere with evaluations; No use of tanning booths, sun lamps, etc.
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
Skin Care Research, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Gwinnett Clinical Research
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Derm Research, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
DermResearch Center of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Dermatology Research Associates
City
Cincinnatti
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
Yardley Dermatology Associates
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20677537
Citation
Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.
Results Reference
result
Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Description
FDA's Drug Finder

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A Study of Different Use Regimens Using Two Acne Treatments

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