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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128723
• Other study ID #: CO-170125113728-SACT
• Status: Completed
• Phase: N/A
• Start date: April 30, 2017
• Est. completion date: June 8, 2017

Study information

• Verified date: August 2018
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 8, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Tennessee Clinical Research Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Willis CM, Shaw S, De Lacharrière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous Tolerance Scores: Erythema	Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 28. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.	Baseline to Day 28
Primary	Cutaneous Tolerance Scores: Dryness/Scaling	Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 28. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.	Baseline to Day 28
Primary	Cutaneous Tolerance Scores: Edema	Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 28. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.	Baseline to Day 28
Primary	Cutaneous Tolerance Scores: Burning/Stinging	Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 28. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.	Baseline to Day 28
Primary	Cutaneous Tolerance Scores: Itching	Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 28. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.	Baseline to Day 28
Primary	Cutaneous Tolerance Scores: Tightness/Dry Feeling	Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 28. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.	Baseline to Day 28
Secondary	Cutaneous Tolerance Scores: Erythema	Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 14. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.	Baseline to Day 14
Secondary	Cutaneous Tolerance Scores: Dryness/Scaling	Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 14. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.	Baseline to Day 14
Secondary	Cutaneous Tolerance Scores: Edema	Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 14. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.	Baseline to Day 14
Secondary	Cutaneous Tolerance Scores: Burning/Stinging	Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 14. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.	Baseline to Day 14
Secondary	Cutaneous Tolerance Scores: Itching	Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 14. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.	Baseline to Day 14
Secondary	Cutaneous Tolerance Scores: Tightness/Dry	Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 14. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.	Baseline to Day 14