A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne
NCT ID: NCT03124381
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2017-04-08
2017-09-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acne Mask
Cleanser, Acne Mask
Cleanser, Acne Mask
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.
Gel-Cream + Acne Mask
Cleanser, Gel-Cream, Acne Mask
Cleanser, Gel-Cream, Acne Mask
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.
Interventions
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Cleanser, Acne Mask
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.
Cleanser, Gel-Cream, Acne Mask
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
40 Years
ALL
No
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Alicia Bucko, D.O.
Role: PRINCIPAL_INVESTIGATOR
Academic Dermatology Associates
Lily Jiang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Thomas J. Stephens & Associates, Inc.
Locations
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Academic Dermatology Associates
Albuquerque, New Mexico, United States
Thomas J. Stephens and Associates, Inc.
Richardson, Texas, United States
Countries
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References
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Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. doi: 10.1111/j.1574-695X.2003.tb00644.x.
Kjeldstad B. Photoinactivation of Propionibacterium acnes by near-ultraviolet light. Z Naturforsch C Biosci. 1984 Mar-Apr;39(3-4):300-2. doi: 10.1515/znc-1984-3-417.
Roelandts R. A new light on Niels Finsen, a century after his Nobel Prize. Photodermatol Photoimmunol Photomed. 2005 Jun;21(3):115-7. doi: 10.1111/j.1600-0781.2005.00160.x. No abstract available.
Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008 Dec;27(4):227-38. doi: 10.1016/j.sder.2008.08.003.
Salomatina E, Jiang B, Novak J, Yaroslavsky AN. Optical properties of normal and cancerous human skin in the visible and near-infrared spectral range. J Biomed Opt. 2006 Nov-Dec;11(6):064026. doi: 10.1117/1.2398928.
Bashkatov, AN, et al. Optical properties of melanin in the skin and skin-like phantoms. Proc. of SPIE, 4162: 219-226, 2000.
Bashkatov, AN, et al. Optical properties of human skin, subcutaneous and mucous tissues in the wavelength range from 400 to 2000 nm. J Phys D: Appl Phys, 38: 2543-2555, 2005.
Jacques SL. Optical properties of biological tissues: a review. Phys Med Biol. 2013 Jun 7;58(11):R37-61. doi: 10.1088/0031-9155/58/11/R37. Epub 2013 May 10.
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.
Pogue BW, Patterson MS. Review of tissue simulating phantoms for optical spectroscopy, imaging and dosimetry. J Biomed Opt. 2006 Jul-Aug;11(4):041102. doi: 10.1117/1.2335429.
Hirshburg J, Choi B, Nelson JS, Yeh AT. Correlation between collagen solubility and skin optical clearing using sugars. Lasers Surg Med. 2007 Feb;39(2):140-4. doi: 10.1002/lsm.20417.
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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PS-170103145529-SACT
Identifier Type: -
Identifier Source: org_study_id
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