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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single Center Clinical Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Device: Acne Mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acne Mask<br>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. | Device: Acne Mask<br>* 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.<br>* Other names: Light Therapy Acne Mask;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne