Comparison of Two Salicylic Acid Formulations

NCT00848744 | Completed Results DMC

• 1 other identifier: AP-011008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Acne Vulgaris

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• Physician Global Assessment

  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).

  28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).

Secondary Outcomes (1)

• The Subject's Medication Side Effect Profile Will be Assessed Using a Application Site Scale for Dryness, Scaling, Redness, and Stinging/Burning.

  4 Weeks

Study Arms (1)

topical salicylic acid 1.0% cream

EXPERIMENTAL

Drug: Formulation A; Drug: Formulation B

Interventions

Formulation A DRUG

Formulation A will be applied to the randomly-assigned single (left or right) side of the face twice daily.

topical salicylic acid 1.0% cream

Formulation B DRUG

Formulation B will be applied to the randomly-assigned single (left or right) side of the face twice daily.

topical salicylic acid 1.0% cream

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy male or female subjects who are 13 to 35 years of age.
• Subjects are in good health and are free of any other facial skin disorders that may interfere with acne study assessments.
• 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.
• 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.
• 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.
• 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.
• 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.
• Subjects who agree not to change facial cosmetic products during the study.
• Subjects who agree to only use sunscreen/sunblock agents that are labeled as non-comedogenic.

You may not qualify if:

• Subjects or parents of subjects who are unable to understand the protocol or to give informed consent/assent.
• Subjects with mental illness.
• Subjects with no inflammatory acne.
• Subjects with any acne cysts or nodules.
• Subjects with acne conglobata, acne fulminans, secondary acne (e.g. Chloracne, drug-induced acne), or any acne requiring systemic treatment.
• Subjects with excessive facial hair that may interfere with study assessments.
• Subjects with other facial skin disorders that may interfere with study assessments.
• Subjects with a history of skin cancer or actinic keratosis.
• Subjects who have used tanning devices within one week prior to baseline study visit.
• 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.
• Use of hormonal oral contraceptives for acne control or for less than 6 months prior to study baseline.
• Subjects with known allergies, a history of allergy or sensitivity to salicylic acid, or any of the test article components.
• 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.
• 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.
• Subjects who are pregnant or nursing.

Sponsors & Collaborators

• Northwestern University: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dermatology CTU
• Organization: Northwestern University

NUdermatologyCTU@northwestern.edu

312-503-5944

Study Officials

• Amy Paller, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

• Dennis P West, PhD

  Northwestern University Department of Dermatology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the department of dermatology

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: February 20, 2009
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 1, 2018
• Results First Posted: July 5, 2010

Record last verified: 2018-01

Locations

US (1)