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

NCT01313728 | Completed Phase 4 Results

• 1 other identifier: CA-P-7966
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

Acne; Irritation

Outcome Measures

Primary Outcomes (2)

• Expert Grader Assessment - Erythema

  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).

  Baseline to 2 Weeks

• Expert Grader Assessment - Dryness

  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).

  Baseline to 2 Weeks

Secondary Outcomes (4)

• Subject Assessment - Burning/Stinging

  Baseline to 2 Weeks

• Subject Assessment - Itching

  Baseline to 2 Weeks

• Subject Assessment - Tightness

  Baseline to 2 Weeks

• Facial Tolerance

  Baseline to 2 Weeks

Study Arms (2)

Dapsone plus Tretinoin Gel

EXPERIMENTAL

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

Tretinoin Gel Alone

ACTIVE COMPARATOR

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

Interventions

Dapsone plus Tretinoin Gel DRUG

Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks

Also known as: Aczone Gel 5% plus Retin-A Micro Gel 0.1% Pump

Dapsone plus Tretinoin Gel

Tretinoin Gel DRUG

Tretinoin gel applied once daily to the assigned side of the face for 2 weeks

Also known as: Retin-A Micro Gel 0.1% Pump

Tretinoin Gel Alone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Skin Study Center

Broomall, Pennsylvania, 19008, United States

Location

Related Links

• FDA's Drug Finder

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dapsone; Tretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: David Lineberry, Associate Director, Clinical Operations
• Organization: Valeant Pharmaceuticals International Inc

David.Lineberry@valeant.com

949-973-1153

Study Officials

• David Lineberry

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 14, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 15, 2012
• Results First Posted: January 19, 2012

Record last verified: 2012-02

Locations

US (1)