Clinical trial NCT03124381: A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne
Official title: 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
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: 2017-04-21
Enrollment: 126
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global Face Total Lesion Count - Percent Change - Baseline to Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Global Face Total Lesion Count - Percent Change - Baseline to Week 2
timeFrame: Baseline and Week 2
measure: Global Face Total Lesion Count - Percent Change - Baseline to Week 4
timeFrame: Baseline and Week 4
measure: Global Face Total Lesion Count - Percent Change - Baseline to Week 8
timeFrame: Baseline and Week 8
measure: Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits
timeFrame: Baseline to Week 2, Week 4, Week 8, and Week 12
measure: Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4
timeFrame: Baseline to Week 2 and Week 4
measure: Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8
timeFrame: Baseline to Week 4 and Week 8
measure: Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12
timeFrame: Baseline to Week 8 and Week 12
measure: Global Face Open Comedones Count - Week 2
timeFrame: 2 weeks
measure: Global Face Open Comedones Count - Week 4
timeFrame: 4 weeks
measure: Global Face Open Comedones Count - Week 8
timeFrame: 8 weeks
measure: Global Face Open Comedones Count - Week 12
timeFrame: 12 weeks
measure: Global Face Closed Comedones Count - Week 2
timeFrame: 2 weeks
measure: Global Face Closed Comedones Count - Week 4
timeFrame: 4 weeks
measure: Global Face Closed Comedones Count - Week 8
timeFrame: 8 weeks
measure: Global Face Closed Comedones Count - Week 12
timeFrame: 12 weeks
measure: Global Face Inflammatory Lesion Count - Week 2
timeFrame: 2 weeks
measure: Global Face Inflammatory Lesion Count - Week 4
timeFrame: 4 weeks
measure: Global Face Inflammatory Lesion Count - Week 8
timeFrame: 8 weeks
measure: Global Face Inflammatory Lesion Count - Week 12
timeFrame: 12 weeks
measure: Global Face Non-Inflammatory Lesion Count - Week 2
timeFrame: 2 weeks
measure: Global Face Non-Inflammatory Lesion Count - Week 4
timeFrame: 4 weeks
measure: Global Face Non-Inflammatory Lesion Count - Week 8
timeFrame: 8 weeks
measure: Global Face Non-Inflammatory Lesion Count - Week 12
timeFrame: 12 weeks
measure: Global Face Total Lesion Count - Week 2
timeFrame: 2 weeks
measure: Global Face Total Lesion Count - Week 4
timeFrame: 4 weeks
measure: Global Face Total Lesion Count - Week 8
timeFrame: 8 weeks
measure: Global Face Total Lesion Count - Week 12
timeFrame: 12 weeks
measure: Investigator Global Acne Assessment - Week 1
timeFrame: 1 week
measure: Investigator Global Acne Assessment - Week 2
timeFrame: 2 weeks
measure: Investigator Global Acne Assessment - Week 4
timeFrame: 4 weeks
measure: Investigator Global Acne Assessment - Week 8
timeFrame: 8 weeks
measure: Investigator Global Acne Assessment - Week 12
timeFrame: 12 weeks
measure: Overall Redness of Inflammatory Lesions - Week 1
timeFrame: 1 week
measure: Overall Redness of Inflammatory Lesions - Week 2
timeFrame: 2 weeks
measure: Overall Redness of Inflammatory Lesions - Week 4
timeFrame: 4 weeks
measure: Overall Redness of Inflammatory Lesions - Week 8
timeFrame: 8 weeks
measure: Overall Redness of Inflammatory Lesions - Week 12
timeFrame: 12 weeks
measure: Overall Size of Inflammatory Lesions - Week 1
timeFrame: 1 week
measure: Overall Size of Inflammatory Lesions - Week 2
timeFrame: 2 weeks
measure: Overall Size of Inflammatory Lesions - Week 4
timeFrame: 4 weeks
measure: Overall Size of Inflammatory Lesions - Week 8
timeFrame: 8 weeks
measure: Overall Size of Inflammatory Lesions - Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Richardson
country: United States
facility: Thomas J. Stephens and Associates, Inc.
state: Texas
Study officials:
affiliation: Academic Dermatology Associates
name: Alicia Bucko, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas J. Stephens & Associates, Inc.
name: Lily Jiang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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citation: Lamouche G, Kennedy BF, Kennedy KM, Bisaillon CE, Curatolo A, Campbell G, Pazos V, Sampson DD. Review of tissue simulating phantoms with controllable optical, mechanical and structural properties for use in optical coherence tomography. Biomed Opt Express. 2012 Jun 1;3(6):1381-98. doi: 10.1364/BOE.3.001381. Epub 2012 May 15.
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citation: Wiegand, B, Luedtke, K, Rapp, SR. Acne Profile. Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933-7003, assignee. Patent US 2006/0008484 A1. 12 Jan. 2006. Print.