Comparison of Two Salicylic Acid Formulations

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00848744
• Collaborator: Ann & Robert H Lurie Children's Hospital of Chicago (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Formulation A; Drug: Formulation B	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: topical salicylic acid 1.0% cream	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.

Outcome Measures

Primary Outcome Measures

1. Physician Global Assessment [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).

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611

Sponsors and Collaborators

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

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amy Paller, Chair of the department of dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT00848744
• Other Study ID Numbers: AP-011008
• First Posted: Feb 20, 2009
• Last Update Posted: Mar 1, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Amy Paller, Chair of the department of dermatology, Northwestern University: Acne
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	Salicylic Acid
Arm/Group Description	Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Salicylic Acid
Arm/Group Description	Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Overall Participants	10
Age (Count of Participants)
<=18 years	6 60%
Between 18 and 65 years	4 40%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	6 60%
Male	4 40%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Physician Global Assessment
Description	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).
Time Frame	28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).

Outcome Measure Data

Analysis Population Description

Analysis was per protocol. Each subject received formulations A and B randomized to opposite sides of the face.

Arm/Group Title	Salicylic Acid	Formulation B
Arm/Group Description	Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on	Participants used salicylic acid Formulation A on either the right or left side of the face.
Measure Participants	10	10
Baseline	2.65 (0.41)	2.6 (0.52)
Day 2	2.55 (0.44)	2.45 (0.55)
Day 7	2.4 (0.61)	2.3 (0.59)
Day 28	2.20 (0.63)	2.15 (0.58)

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Data were not collected.

Arm/Group Title	Salicylic Acid	Formulation B
Arm/Group Description	Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on	Participants used salicylic acid Formulation A on either the right or left side of the face.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Salicylic Acid
Arm/Group Description	Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
All Cause Mortality
	Salicylic Acid
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Salicylic Acid
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Salicylic Acid
	Affected / at Risk (%)	# Events
Total	1/10 (10%)
Skin and subcutaneous tissue disorders
irritation and swelling of face	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.