A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01313728
First received: March 10, 2011
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.


Condition Intervention Phase
Acne Vulgaris
Drug: Dapsone plus Tretinoin Gel
Drug: Tretinoin Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: An Investigator-Blind, Phase 4 Study Assessing Mitigation of Facial Irritation When Comparing the Use of Two Acne Treatment Products (Retin-A Micro® 0.1 % Pump and Aczone®) With One Treatment Product (Retin-A Micro® 0.1 % Pump) Using a Split-Face Model

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Expert Grader Assessment - Erythema [ Time Frame: Baseline to 2 Weeks ] [ Designated as safety issue: No ]
    Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).

  • Expert Grader Assessment - Dryness [ Time Frame: Baseline to 2 Weeks ] [ Designated as safety issue: No ]
    Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).


Secondary Outcome Measures:
  • Subject Assessment - Burning/Stinging [ Time Frame: Baseline to 2 Weeks ] [ Designated as safety issue: No ]
    Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).

  • Subject Assessment - Itching [ Time Frame: Baseline to 2 Weeks ] [ Designated as safety issue: No ]
    Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).

  • Subject Assessment - Tightness [ Time Frame: Baseline to 2 Weeks ] [ Designated as safety issue: No ]
    Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).

  • Facial Tolerance [ Time Frame: Baseline to 2 Weeks ] [ Designated as safety issue: No ]
    All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).


Enrollment: 26
Study Start Date: December 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapsone plus Tretinoin Gel
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Drug: Dapsone plus Tretinoin Gel
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks
Other Name: Aczone Gel 5% plus Retin-A Micro Gel 0.1% Pump
Active Comparator: Tretinoin Gel Alone
Tretinoin gel applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Drug: Tretinoin Gel
Tretinoin gel applied once daily to the assigned side of the face for 2 weeks
Other Name: Retin-A Micro Gel 0.1% Pump

Detailed Description:

This is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying Aczone Gel first) and Retin-A Micro Gel 0.1 % Pump to the other side of the face in a randomized scheme for two consecutive weeks. Subjects will return to the study center daily for evaluation and for application of both products (weekend applications will be done at home). At each visit the subject will be evaluated and scored for irritation and cutaneous treatment effects. Subjects presenting with differences in irritation between one side of the face and the other will be photographed and have chromometer readings taken. A single treatment center is expected to enroll at least 24 subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fitzpatrick Skin Type I, II or III with healthy skin as judged by the investigator
  • Bilateral skin is clear of any confounding irritation, rashes, acne, rosacea, etc., prior to study start
  • Subjects are willing to avoid applying emollients or cosmetics to the face 24 hours before they start, and during the study
  • If subject is of childbearing potential, subject has been using a protocol-approved method of birth control for a certain amount of time, and is willing to continue using it throughout the study

Exclusion Criteria:

  • Subjects who are pregnant or nursing, or intend to be during the study
  • Subjects with any condition or medical history, or using any drug or medication, that might negatively affect the subject's safety or the validity of study results, either as listed in the protocol or in the opinion of the investigator
  • Subjects who have facial hair that may obstruct or hinder the evaluation of any reactions
  • Subjects who use any known photosensitizing agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313728

Locations
United States, Pennsylvania
Skin Study Center
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: David Lineberry Valeant Pharmaceuticals International, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01313728     History of Changes
Other Study ID Numbers: CA-P-7966
Study First Received: March 10, 2011
Results First Received: October 14, 2011
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Acne
Irritation

Additional relevant MeSH terms:
Tretinoin
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dapsone
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on July 29, 2014