Clinical trial NCT03128723: A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris
Official title: A Single Center Clinical Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: Acne
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cutaneous Tolerance Scores: Erythema
timeFrame: Baseline to Day 28
measure: Cutaneous Tolerance Scores: Dryness/Scaling
timeFrame: Baseline to Day 28
measure: Cutaneous Tolerance Scores: Edema
timeFrame: Baseline to Day 28
measure: Cutaneous Tolerance Scores: Burning/Stinging
timeFrame: Baseline to Day 28
measure: Cutaneous Tolerance Scores: Itching
timeFrame: Baseline to Day 28
measure: Cutaneous Tolerance Scores: Tightness/Dry Feeling
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Cutaneous Tolerance Scores: Erythema
timeFrame: Baseline to Day 14
measure: Cutaneous Tolerance Scores: Dryness/Scaling
timeFrame: Baseline to Day 14
measure: Cutaneous Tolerance Scores: Edema
timeFrame: Baseline to Day 14
measure: Cutaneous Tolerance Scores: Burning/Stinging
timeFrame: Baseline to Day 14
measure: Cutaneous Tolerance Scores: Itching
timeFrame: Baseline to Day 14
measure: Cutaneous Tolerance Scores: Tightness/Dry
timeFrame: Baseline to Day 14
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
Study officials:
affiliation: Tennessee Clinical Research Center
name: Michael H Gold, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muizzuddin N, Marenus KD, Maes DH. Factors defining sensitive skin and its treatment. Am J Contact Dermat. 1998 Sep;9(3):170-5.
citation: 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.
citation: 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.