A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris

NCT ID: NCT03128723

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2017-06-08

Brief Summary

The study will look to evaluate the tolerance of a light therapy-based acne mask device in participants who report having sensitive skin. All participants will receive a cleanser, a light therapy mask, and an extra activator for the light therapy mask.

Detailed Description

Acne and sensitive skin can be closely connected due to the reported involvement of an impaired skin barrier in both conditions, which can be further aggravated by potentially irritating topical treatments.

A patient's sensitive skin may be caused by the skincare products that they are using, the amount that they are applying (over-usage), or the concomitant effect of the different products being used, as well as by underlying medical conditions. While sensitive skin can be self-perceived and sometimes clinically apparent, as there is no agreed upon medical definition of 'sensitive skin', it is a 'diagnosis' primarily made by the patient's perception. The high incidence of this problem and potential for further irritation due to current topical treatments has left many patients in need of a sensitive skin solution for their acne.

Current at-home topical treatments for mild to moderate acne include Over-the-Counter (OTC) options, primarily with either benzoyl peroxide, or salicylic acid, as well as prescription options including retinoid-based products, however the cutaneous irritation potential of topical acne active ingredients has been reported in the literature, which is not desirable in particular for patients with sensitive skin.

Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with blue light reported to target acne-causing bacteria and red light demonstrating anti-inflammatory activity. Previous studies with these types of modalities have shown high tolerance and efficacy. This study will look to evaluate the tolerance of a light therapy-based medical device in patients with self-reported sensitive skin.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acne Mask

The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.

Group Type: EXPERIMENTAL

Acne Mask

Intervention Type: DEVICE

The light therapy acne mask contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes.

Interventions

Acne Mask

The light therapy acne mask contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes.

Intervention Type: DEVICE

Other Intervention Names

Light Therapy Acne Mask

Eligibility Criteria

Inclusion Criteria

• In good general health
• Has mild to moderate facial acne
• Has sensitive skin per sensitive skin questionnaires
• Has score of "0" or "1" in all tolerance parameters (erythema, dryness/scaling, edema, burning/stinging, itching, and tightness/dryness feeling)
• Able to read, write, speak, and understand English
• Must agree to practice a medically acceptable form of birth control

Exclusion Criteria

• Has known light or photo-sensitivity disorder
• Has very sensitive skin or known allergies to skincare products or the cleanser ingredients
• Has severe acne or pre-existing facial skin conditions other than mild to moderate acne
• Females that are pregnant, nursing, or planning to become pregnant
• Males with a female partner who is pregnant or planning to become pregnant
• Has been using a product or medication that the investigator determines will increase health risk to the subject or confuse the study results
• Is participating or has participated in another study with the past 30 days
• Has history of immunosuppression/immune deficiency disorders
• Has planned surgeries or invasive medical procedures scheduled during the study
• Is related to the Sponsor, Investigator, or Study Site

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Gold, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tennessee Clinical Research Center

Locations

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Countries

United States

References

Muizzuddin N, Marenus KD, Maes DH. Factors defining sensitive skin and its treatment. Am J Contact Dermat. 1998 Sep;9(3):170-5.

Reference Type: BACKGROUND

PMID: 9744910 (View on PubMed)

Willis CM, Shaw S, De Lacharriere O, Baverel M, Reiche L, Jourdain R, Bastien P, Wilkinson JD. Sensitive skin: an epidemiological study. Br J Dermatol. 2001 Aug;145(2):258-63. doi: 10.1046/j.1365-2133.2001.04343.x.

Reference Type: BACKGROUND

PMID: 11531788 (View on PubMed)

Sagransky M, Yentzer BA, Feldman SR. Benzoyl peroxide: a review of its current use in the treatment of acne vulgaris. Expert Opin Pharmacother. 2009 Oct;10(15):2555-62. doi: 10.1517/14656560903277228.

Reference Type: BACKGROUND

PMID: 19761357 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CO-170125113728-SACT

Identifier Type: -

Identifier Source: org_study_id