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

Not Applicable

Completed

Conditions: Acne Vulgaris

Interventions: Device: Cleanser, Gel-Cream, Acne Mask
Device: Cleanser, Acne Mask

Registration Number: NCT03124381

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

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 126

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gel-Cream + Acne Mask	Cleanser, Gel-Cream, Acne Mask	Cleanser, Gel-Cream, Acne Mask
Acne Mask	Cleanser, Acne Mask	Cleanser, Acne Mask

Primary Outcome Measures

Name	Time	Method
Global Face Total Lesion Count - Percent Change - Baseline to Week 12	Baseline and Week 12	Percent change from baseline in global face total lesion count at Week 12

Secondary Outcome Measures

Name	Time	Method
Global Face Non-Inflammatory Lesion Count - Week 8	8 weeks	Sum of open comedones and closed comedones
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12	Baseline to 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.
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8	Baseline to 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.
Global Face Closed Comedones Count - Week 12	12 weeks	Closed comedones count on global face - Week 12
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4	Baseline to 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.
Global Face Open Comedones Count - Week 2	2 weeks	Open comedones count on global face - Week 2
Global Face Total Lesion Count - Percent Change - Baseline to Week 2	Baseline and Week 2	Percent change from baseline in global face total lesion count at Week 2
Global Face Total Lesion Count - Percent Change - Baseline to Week 4	Baseline and Week 4	Percent change from baseline in global face total lesion count at Week 4
Global Face Total Lesion Count - Percent Change - Baseline to Week 8	Baseline and Week 8	Percent change from baseline in global face total lesion count at Week 8
Global Face Open Comedones Count - Week 12	12 weeks	Open comedones count on global face - Week 12
Global Face Inflammatory Lesion Count - Week 2	2 weeks	Papules and pustules counted together
Global Face Inflammatory Lesion Count - Week 8	8 weeks	Papules and pustules counted together
Global Face Non-Inflammatory Lesion Count - Week 2	2 weeks	Sum of open comedones and closed comedones
Global Face Non-Inflammatory Lesion Count - Week 12	12 weeks	Sum of open comedones and closed comedones
Global Face Total Lesion Count - Week 8	8 weeks	Sum of inflammatory and non-inflammatory lesions
Investigator Global Acne Assessment - Week 1	1 week	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.
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits	Baseline to Week 2, Week 4, Week 8, and Week 12	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.
Global Face Open Comedones Count - Week 4	4 weeks	Open comedones count on global face - Week 4
Investigator Global Acne Assessment - Week 8	8 weeks	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.
Investigator Global Acne Assessment - Week 12	12 weeks	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.
Overall Redness of Inflammatory Lesions - Week 1	1 week	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
Global Face Open Comedones Count - Week 8	8 weeks	Open comedones count on global face - Week 8
Global Face Inflammatory Lesion Count - Week 12	12 weeks	Papules and pustules counted together
Global Face Total Lesion Count - Week 12	12 weeks	Sum of inflammatory and non-inflammatory lesions
Investigator Global Acne Assessment - Week 2	2 weeks	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.
Overall Redness of Inflammatory Lesions - Week 12	12 weeks	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
Global Face Closed Comedones Count - Week 2	2 weeks	Closed comedones count on global face - Week 2
Global Face Closed Comedones Count - Week 4	4 weeks	Closed comedones count on global face - Week 4
Global Face Closed Comedones Count - Week 8	8 weeks	Closed comedones count on global face - Week 8
Global Face Inflammatory Lesion Count - Week 4	4 weeks	Papules and pustules counted together
Global Face Non-Inflammatory Lesion Count - Week 4	4 weeks	Sum of open comedones and closed comedones
Global Face Total Lesion Count - Week 4	4 weeks	Sum of inflammatory and non-inflammatory lesions
Investigator Global Acne Assessment - Week 4	4 weeks	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.
Overall Redness of Inflammatory Lesions - Week 4	4 weeks	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
Overall Size of Inflammatory Lesions - Week 2	2 weeks	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Overall Size of Inflammatory Lesions - Week 12	12 weeks	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Global Face Total Lesion Count - Week 2	2 weeks	Sum of inflammatory and non-inflammatory lesions
Overall Redness of Inflammatory Lesions - Week 2	2 weeks	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
Overall Redness of Inflammatory Lesions - Week 8	8 weeks	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
Overall Size of Inflammatory Lesions - Week 1	1 week	Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Overall Size of Inflammatory Lesions - Week 4	4 weeks	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Overall Size of Inflammatory Lesions - Week 8	8 weeks	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.

Trial Locations

Locations (2): Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
Thomas J. Stephens and Associates, Inc.
🇺🇸
Richardson, Texas, United States