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

NCT03124381 | Completed Results FDA Device

• 1 other identifier: PS-170103145529-SACT
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (42)

• Global Face Total Lesion Count - Percent Change - Baseline to Week 2

  Baseline and Week 2

• Global Face Total Lesion Count - Percent Change - Baseline to Week 4

  Baseline and Week 4

• Global Face Total Lesion Count - Percent Change - Baseline to Week 8

  Baseline and Week 8

• 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 Count - Percent Change From Baseline to the Mean of Week 2 and Week 4

  Baseline to Week 2 and Week 4

Study Arms (2)

Acne Mask

ACTIVE COMPARATOR

Cleanser, Acne Mask

Device: Cleanser, Acne Mask

Gel-Cream + Acne Mask

EXPERIMENTAL

Cleanser, Gel-Cream, Acne Mask

Device: Cleanser, Gel-Cream, Acne Mask

Interventions

Cleanser, Acne Mask DEVICE

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.

Also known as: Light Therapy Mask

Acne Mask

Cleanser, Gel-Cream, Acne Mask DEVICE

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.

Also known as: Light Therapy Mask, Light Therapy Topical Gel-Cream

Gel-Cream + Acne Mask

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (2)

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Thomas J. Stephens and Associates, Inc.

Richardson, Texas, 75081, United States

Location

Related Publications (12)

• 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.

  PMID: 12589953 BACKGROUND

• 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.

  PMID: 6730638 BACKGROUND

• 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.

  PMID: 15888126 BACKGROUND

• 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.

  PMID: 19150294 BACKGROUND

• 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.

  PMID: 17212549 BACKGROUND

• Bashkatov, AN, et al. Optical properties of melanin in the skin and skin-like phantoms. Proc. of SPIE, 4162: 219-226, 2000.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23666068 BACKGROUND

• 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.

  PMID: 22741083 BACKGROUND

• 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.

  PMID: 16965130 BACKGROUND

• 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.

  PMID: 17311267 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Ali Fassih, Ph.D.
• Organization: Johnson & Johnson Consumer Inc.

Afassih@its.jnj.com

908-904-3259

Study Officials

• Alicia Bucko, D.O.

  Academic Dermatology Associates

  PRINCIPAL INVESTIGATOR

• Lily Jiang, Ph.D.

  Thomas J. Stephens & Associates, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Evaluator-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 21, 2017
• Study Start: April 8, 2017
• Primary Completion: September 6, 2017
• Study Completion: September 6, 2017
• Last Updated: February 15, 2019
• Results First Posted: November 9, 2018

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)