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

• ClinicalTrials.gov Identifier: NCT01313728
• Recruitment Status: Completed
• First Posted: March 14, 2011
• Results First Posted: January 19, 2012
• Last Update Posted: February 15, 2012
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Dapsone plus Tretinoin Gel; Drug: Tretinoin Gel	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (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
• Study Start Date: December 2010
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Expert Grader Assessment - Erythema [ Time Frame: Baseline to 2 Weeks ]
   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).
2. Expert Grader Assessment - Dryness [ Time Frame: Baseline to 2 Weeks ]
   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 :

1. Subject Assessment - Burning/Stinging [ Time Frame: Baseline to 2 Weeks ]
   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).
2. Subject Assessment - Itching [ Time Frame: Baseline to 2 Weeks ]
   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).
3. Subject Assessment - Tightness [ Time Frame: Baseline to 2 Weeks ]
   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).
4. Facial Tolerance [ Time Frame: Baseline to 2 Weeks ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Pennsylvania

Skin Study Center

Broomall, Pennsylvania, United States, 19008

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

• Study Director: David Lineberry; Bausch Health Americas, Inc.

More Information

Additional Information:

FDA's Drug Finder 

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT01313728
• Other Study ID Numbers: CA-P-7966
• First Posted: March 14, 2011
• Results First Posted: January 19, 2012
• Last Update Posted: February 15, 2012
• Last Verified: February 2012

Keywords provided by Bausch Health Americas, Inc.:

Acne; Irritation

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Dapsone; Tretinoin; Antineoplastic Agents; Keratolytic Agents; Dermatologic Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Folic Acid Antagonists; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Leprostatic Agents; Anti-Bacterial Agents