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Comparison of Two Salicylic Acid Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00848744
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : July 5, 2010
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Tracking Information
First Submitted Date  ICMJE November 24, 2008
First Posted Date  ICMJE February 20, 2009
Results First Submitted Date  ICMJE November 10, 2009
Results First Posted Date  ICMJE July 5, 2010
Last Update Posted Date March 1, 2018
Study Start Date  ICMJE February 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Physician Global Assessment [ Time Frame: 28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3). ]
Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicylic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
Determine if the Formulation A will globally improve resolution of acne lesions by Physician Global Assessment when compared to the application of Formulation B. [ Time Frame: 4 Weeks ]
Change History Complete list of historical versions of study NCT00848744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
The Subject's Medication Side Effect Profile Will be Assessed Using a Application Site Scale for Dryness, Scaling, Redness, and Stinging/Burning. [ Time Frame: 4 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Salicylic Acid Formulations
Official Title  ICMJE A Split-Face, Paired-Comparison, Pilot Study to Evaluate Safety and Efficacy of Two Topical Salicylic Acid 1.0% Creams for Mild to Moderate Acne Vulgaris
Brief Summary This study is a split face, paired-comparison, pilot study of at least 10 subjects to complete. Participants in this study will be patients seen at Children's Memorial Hospital, who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be recruited from one of the clinics, as well as from previous Institutional Review Board (IRB) approved acne studies housed in the Department of Dermatology. All subjects accrued from previous studies have agreed to be contacted for further investigations. Subjects 13 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face, and meeting inclusion criteria will be eligible to participate
Detailed Description

Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules)1.

The basic cause of acne remains unknown, but its manifestations are thought to be the product of four pathogenic events: 1) increased sebum production fueled by androgenic stimulation in the pubertal period; 2) obstruction of the pilosebaceous unit due to an abnormal keratinization process; 3) proliferation of Propionibacterium acnes, an anaerobic diphtheroid normally residing in pilosebaceous follicles; and 4) inflammation that is mediated both by the action of chemotactic factors and various enzymes, and initiated in part by the interaction of P. acnes with toll-like receptors. Impaction of the pilosebaceous follicle gives rise to the microcomedo that is thought to be the precursor lesion of acne1.

Topical salicylic acid is a common and well-established agent with known keratolytic properties used in the treatment of acne vulgaris. The safety profile for topical salicylic acid has been well delineated. The most common side effects attributed to salicylic acid products include irritation, dryness, scaling, burning and stinging.

Salicylic acid 1.0% creams (Formulation A and Formulation B) will be evaluated to detect any differences in their response for safety and efficacy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Formulation A
    Formulation A will be applied to the randomly-assigned single (left or right) side of the face twice daily.
  • Drug: Formulation B
    Formulation B will be applied to the randomly-assigned single (left or right) side of the face twice daily.
Study Arms  ICMJE Experimental: topical salicylic acid 1.0% cream
Interventions:
  • Drug: Formulation A
  • Drug: Formulation B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2009)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male or female subjects who are 13 to 35 years of age.
  2. Subjects are in good health and are free of any other facial skin disorders that may interfere with acne study assessments.
  3. Subjects have the willingness and ability to understand and provide informed assent/consent to participate in the study and are able to communicate with the investigator. Subjects are willing and able to follow all study directions and to commit to all follow-up visits for the duration of the study. In addition, subjects must be willing to accept the restrictions of the study.
  4. A minimum of 5 inflammatory lesions (papules and pustules) on each side of the face, and a minimum of 5 non-inflammatory lesions (open comedones and closed comedones on each side of the face. Lesions should be relatively symmetrical in appearance on both sides of the face. At least one inflammatory lesion should be measured no smaller than 2 mm in diameter and should be visible on each side of the face in images taken with digital imaging station.
  5. Ongoing oral medications (other than those specifically for acne) are acceptable provided subjects are on a stable regimen throughout the study and provided the medications are determined likely to not interfere with study assessments.
  6. Subjects will not use medicated cosmetics and/or soaps (including soaps containing antibacterial agents such as benzoyl peroxide, keratolytic agents such as salicylic acid, skin fresheners/astringents or aftershave lotions) for the duration of the study.
  7. Subjects who agree not use any other acne treatment (including prescription and non-prescription medications) on the test site for the duration of the study.
  8. Subjects who agree not to change facial cosmetic products during the study.
  9. Subjects who agree to only use sunscreen/sunblock agents that are labeled as non-comedogenic.

Exclusion Criteria:

  1. Subjects or parents of subjects who are unable to understand the protocol or to give informed consent/assent.
  2. Subjects with mental illness.
  3. Subjects with no inflammatory acne.
  4. Subjects with any acne cysts or nodules.
  5. Subjects with acne conglobata, acne fulminans, secondary acne (e.g. Chloracne, drug-induced acne), or any acne requiring systemic treatment.
  6. Subjects with excessive facial hair that may interfere with study assessments.
  7. Subjects with other facial skin disorders that may interfere with study assessments.
  8. Subjects with a history of skin cancer or actinic keratosis.
  9. Subjects who have used tanning devices within one week prior to baseline study visit.
  10. Subjects who have applied any topical products (e.g. emollients, sunscreens) or any cosmetics to the face at least one hour prior to study assessments.
  11. Use of hormonal oral contraceptives for acne control or for less than 6 months prior to study baseline.
  12. Subjects with known allergies, a history of allergy or sensitivity to salicylic acid, or any of the test article components.
  13. Subjects using topical or systemic medication within 14 days before the study entry, which could interfere with study assessments. This includes but is not limited to the following: anti-inflammatory drugs (e.g. topical and systemic corticosteroids and systemic antihistamines), anti-acne drugs, topical and oral retinoids, topical antibacterial agents to the face, and any immunosuppressive drugs. Ongoing oral medications not expected to interfere with study assessments are allowed if the subject is on a stable regimen.
  14. Subjects who are currently enrolled in another clinical investigation or have been enrolled in an acne trial within a period of 30 days prior to enrollment in this study.
  15. Subjects who are pregnant or nursing.
  16. Subjects who require electrolysis, waxing, or depilatories on the face during conduct of the study.
  17. Subjects viewed by the investigator as not being able to complete the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00848744
Other Study ID Numbers  ICMJE AP-011008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy Paller, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Ann & Robert H Lurie Children's Hospital of Chicago
Investigators  ICMJE
Principal Investigator: Amy Paller, MD Ann & Robert H Lurie Children's Hospital of Chicago
Study Director: Dennis P West, PhD Northwestern University Department of Dermatology
PRS Account Northwestern University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP