A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne

Study Overview
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Brief Summary
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This study will compare two different acne treatment regimens for the treatment of acne. Half of participants will receive a cleanser and a light therapy mask, while half of the participants will receive a cleanser, a light therapy topical gel-cream, and a light therapy mask.

Detailed Description
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Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompany sebaceous glands. Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with red and blue light shown to target acne-causing bacteria and have an effect on inflammation reduction. Light-based therapies have been used successfully to treat dermatological conditions since the early 1900s, with various parts of the electromagnetic spectrum (i.e. ultraviolet [UV], visible, near-infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs) offer delivery of light to the skin in a gentler manner as compared to light delivered by lasers, primarily due to the lower energy output. It has been reported that LEDs do not deliver enough power to damage tissues and do not have the same risk of accidental eye damage that lasers do. Visible-LED light therapy has been deemed a non-significant risk by the U.S. Food and Drug Administration (FDA) and has been approved for use in humans. It is well established in the literature that visible light penetration into the epidermal and dermal layers of human skin is primarily governed by absorption and scattering events, with the latter being the more impactful of the two. Visible light penetration into human skin can be increased by reducing scattering. This can be accomplished by temporary hydrogen bonding disruption, which leads to the reversible rearrangement of epidermal and dermal structures that cause scattering. Glycerol (i.e. glycerin) is hypothesized to generate the level of hydrogen bonding disruption described above, and therefore will be investigated in the present study. This study will look to evaluate and then compare the acne clearing efficacy and tolerance of two different acne treatment regimens - a cleanser used with a currently marketed red and blue light acne light therapy mask alone vs. the cleanser used with the same mask in conjunction with a light therapy topical gel-cream - to determine the efficacy of these treatments and then to assess if the efficacy of the light therapy mask used with the topical gel-cream treatment is non-inferior to the mask alone in the reduction of lesions in mild to moderate acne. If non-inferiority is demonstrated, the mask with topical gel-cream treatment will be further assessed for its superiority to the mask alone.

Official Title
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A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne Treatment Regimens on Subjects With Mild to Moderate Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Device: Cleanser, Acne Mask
* Device: Cleanser, Gel-Cream, Acne Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has mild to moderate facial acne Has 10-100 blackheads/whiteheads, 10-50 pimples, no cysts, and up to 2 large, hard, painful bumps (nodules) Able to read, write, speak, and understand English In general good health Must agree to practice a medically acceptable form of birth control. Intends to complete the study and willing to follow all study instructions. Exclusion Criteria: Very sensitive skin or allergies/sensitivity to skincare products or the test product ingredients. Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results Is using medication that makes skin more sensitive to light Has severe acne or a pre-existing facial skin condition other than mild to moderate acne has an immune deficiency disorder has been using a product or medication that the stuff investigator determines will increase health risk to the subject or confuse the study results Females that are pregnant, nursing, or planning to become pregnant Males with a female partner who is pregnant or planning to become pregnant Has excessive facial hair Is participating in another study within past 4 weeks 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acne Mask<br>Cleanser, Acne Mask | Device: Cleanser, Acne Mask<br>* A facial cleanser will be used twice daily (morning and evening). The light therapy mask will be used for 10 minutes in the evening after washing/drying the face.<br>* Other names: Light Therapy Mask;|
| Experimental: Gel-Cream + Acne Mask<br>Cleanser, Gel-Cream, Acne Mask | Device: Cleanser, Gel-Cream, Acne Mask<br>* A facial cleanser will be used twice daily (morning and evening). In the evening after cleansing, the gel-cream will be applied full face and allowed to dry before the light therapy mask is used for 10 minutes.<br>* Other names: Light Therapy Topical Gel-Cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Face Total Lesion Count - Percent Change - Baseline to Week 12 | Percent change from baseline in global face total lesion count at Week 12 | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Face Total Lesion Count - Percent Change - Baseline to Week 2 | Percent change from baseline in global face total lesion count at Week 2 | Baseline and Week 2 | 
| Global Face Total Lesion Count - Percent Change - Baseline to Week 4 | Percent change from baseline in global face total lesion count at Week 4 | Baseline and Week 4 | 
| Global Face Total Lesion Count - Percent Change - Baseline to Week 8 | Percent change from baseline in global face total lesion count at Week 8 | Baseline and Week 8 | 
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits | Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated. | Baseline to Week 2, Week 4, Week 8, and Week 12 | 
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4 | Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated. | Baseline to Week 2 and Week 4 | 
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8 | Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated. | Baseline to Week 4 and Week 8 | 
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12 | Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated. | Baseline to Week 8 and Week 12 | 
| Global Face Open Comedones Count - Week 2 | Open comedones count on global face - Week 2 | 2 weeks | 
| Global Face Open Comedones Count - Week 4 | Open comedones count on global face - Week 4 | 4 weeks | 
| Global Face Open Comedones Count - Week 8 | Open comedones count on global face - Week 8 | 8 weeks | 
| Global Face Open Comedones Count - Week 12 | Open comedones count on global face - Week 12 | 12 weeks | 
| Global Face Closed Comedones Count - Week 2 | Closed comedones count on global face - Week 2 | 2 weeks | 
| Global Face Closed Comedones Count - Week 4 | Closed comedones count on global face - Week 4 | 4 weeks | 
| Global Face Closed Comedones Count - Week 8 | Closed comedones count on global face - Week 8 | 8 weeks | 
| Global Face Closed Comedones Count - Week 12 | Closed comedones count on global face - Week 12 | 12 weeks | 
| Global Face Inflammatory Lesion Count - Week 2 | Papules and pustules counted together | 2 weeks | 
| Global Face Inflammatory Lesion Count - Week 4 | Papules and pustules counted together | 4 weeks | 
| Global Face Inflammatory Lesion Count - Week 8 | Papules and pustules counted together | 8 weeks | 
| Global Face Inflammatory Lesion Count - Week 12 | Papules and pustules counted together | 12 weeks | 
| Global Face Non-Inflammatory Lesion Count - Week 2 | Sum of open comedones and closed comedones | 2 weeks | 
| Global Face Non-Inflammatory Lesion Count - Week 4 | Sum of open comedones and closed comedones | 4 weeks | 
| Global Face Non-Inflammatory Lesion Count - Week 8 | Sum of open comedones and closed comedones | 8 weeks | 
| Global Face Non-Inflammatory Lesion Count - Week 12 | Sum of open comedones and closed comedones | 12 weeks | 
| Global Face Total Lesion Count - Week 2 | Sum of inflammatory and non-inflammatory lesions | 2 weeks | 
| Global Face Total Lesion Count - Week 4 | Sum of inflammatory and non-inflammatory lesions | 4 weeks | 
| Global Face Total Lesion Count - Week 8 | Sum of inflammatory and non-inflammatory lesions | 8 weeks | 
| Global Face Total Lesion Count - Week 12 | Sum of inflammatory and non-inflammatory lesions | 12 weeks | 
| Investigator Global Acne Assessment - Week 1 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 1 week | 
| Investigator Global Acne Assessment - Week 2 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 2 weeks | 
| Investigator Global Acne Assessment - Week 4 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 4 weeks | 
| Investigator Global Acne Assessment - Week 8 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 8 weeks | 
| Investigator Global Acne Assessment - Week 12 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 12 weeks | 
| Overall Redness of Inflammatory Lesions - Week 1 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 1 week | 
| Overall Redness of Inflammatory Lesions - Week 2 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 2 weeks | 
| Overall Redness of Inflammatory Lesions - Week 4 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 4 weeks | 
| Overall Redness of Inflammatory Lesions - Week 8 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 8 weeks | 
| Overall Redness of Inflammatory Lesions - Week 12 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 12 weeks | 
| Overall Size of Inflammatory Lesions - Week 1 | Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | 1 week | 
| Overall Size of Inflammatory Lesions - Week 2 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | 2 weeks | 
| Overall Size of Inflammatory Lesions - Week 4 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | 4 weeks | 
| Overall Size of Inflammatory Lesions - Week 8 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large. | 8 weeks | 
| Overall Size of Inflammatory Lesions - Week 12 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | 12 weeks | 

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