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

• ClinicalTrials.gov Identifier: NCT03124381
• Recruitment Status: Completed
• First Posted: April 21, 2017
• Results First Posted: November 9, 2018
• Last Update Posted: February 15, 2019
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Device: Cleanser, Acne Mask; Device: Cleanser, Gel-Cream, Acne Mask	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Evaluator-blind
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 8, 2017
• Actual Primary Completion Date: September 6, 2017
• Actual Study Completion Date: September 6, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Acne Mask; Cleanser, Acne Mask	Device: 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.; Other Name: Light Therapy Mask
Experimental: Gel-Cream + Acne Mask; Cleanser, Gel-Cream, Acne Mask	Device: 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 Names: Light Therapy Mask; Light Therapy Topical Gel-Cream

Outcome Measures

Primary Outcome Measures :

1. Global Face Total Lesion Count - Percent Change - Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
   Percent change from baseline in global face total lesion count at Week 12

Secondary Outcome Measures :

1. Global Face Total Lesion Count - Percent Change - Baseline to Week 2 [ Time Frame: Baseline and Week 2 ]
   Percent change from baseline in global face total lesion count at Week 2
2. Global Face Total Lesion Count - Percent Change - Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
   Percent change from baseline in global face total lesion count at Week 4
3. Global Face Total Lesion Count - Percent Change - Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]
   Percent change from baseline in global face total lesion count at Week 8
4. Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits [ Time Frame: 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.
5. Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4 [ Time Frame: 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.
6. Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8 [ Time Frame: 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.
7. Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12 [ Time Frame: 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.
8. Global Face Open Comedones Count - Week 2 [ Time Frame: 2 weeks ]
   Open comedones count on global face - Week 2
9. Global Face Open Comedones Count - Week 4 [ Time Frame: 4 weeks ]
   Open comedones count on global face - Week 4
10. Global Face Open Comedones Count - Week 8 [ Time Frame: 8 weeks ]
    Open comedones count on global face - Week 8
11. Global Face Open Comedones Count - Week 12 [ Time Frame: 12 weeks ]
    Open comedones count on global face - Week 12
12. Global Face Closed Comedones Count - Week 2 [ Time Frame: 2 weeks ]
    Closed comedones count on global face - Week 2
13. Global Face Closed Comedones Count - Week 4 [ Time Frame: 4 weeks ]
    Closed comedones count on global face - Week 4
14. Global Face Closed Comedones Count - Week 8 [ Time Frame: 8 weeks ]
    Closed comedones count on global face - Week 8
15. Global Face Closed Comedones Count - Week 12 [ Time Frame: 12 weeks ]
    Closed comedones count on global face - Week 12
16. Global Face Inflammatory Lesion Count - Week 2 [ Time Frame: 2 weeks ]
    Papules and pustules counted together
17. Global Face Inflammatory Lesion Count - Week 4 [ Time Frame: 4 weeks ]
    Papules and pustules counted together
18. Global Face Inflammatory Lesion Count - Week 8 [ Time Frame: 8 weeks ]
    Papules and pustules counted together
19. Global Face Inflammatory Lesion Count - Week 12 [ Time Frame: 12 weeks ]
    Papules and pustules counted together
20. Global Face Non-Inflammatory Lesion Count - Week 2 [ Time Frame: 2 weeks ]
    Sum of open comedones and closed comedones
21. Global Face Non-Inflammatory Lesion Count - Week 4 [ Time Frame: 4 weeks ]
    Sum of open comedones and closed comedones
22. Global Face Non-Inflammatory Lesion Count - Week 8 [ Time Frame: 8 weeks ]
    Sum of open comedones and closed comedones
23. Global Face Non-Inflammatory Lesion Count - Week 12 [ Time Frame: 12 weeks ]
    Sum of open comedones and closed comedones
24. Global Face Total Lesion Count - Week 2 [ Time Frame: 2 weeks ]
    Sum of inflammatory and non-inflammatory lesions
25. Global Face Total Lesion Count - Week 4 [ Time Frame: 4 weeks ]
    Sum of inflammatory and non-inflammatory lesions
26. Global Face Total Lesion Count - Week 8 [ Time Frame: 8 weeks ]
    Sum of inflammatory and non-inflammatory lesions
27. Global Face Total Lesion Count - Week 12 [ Time Frame: 12 weeks ]
    Sum of inflammatory and non-inflammatory lesions
28. Investigator Global Acne Assessment - Week 1 [ Time Frame: 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.
29. Investigator Global Acne Assessment - Week 2 [ Time Frame: 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.
30. Investigator Global Acne Assessment - Week 4 [ Time Frame: 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.
31. Investigator Global Acne Assessment - Week 8 [ Time Frame: 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.
32. Investigator Global Acne Assessment - Week 12 [ Time Frame: 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.
33. Overall Redness of Inflammatory Lesions - Week 1 [ Time Frame: 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
34. Overall Redness of Inflammatory Lesions - Week 2 [ Time Frame: 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
35. Overall Redness of Inflammatory Lesions - Week 4 [ Time Frame: 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
36. Overall Redness of Inflammatory Lesions - Week 8 [ Time Frame: 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
37. Overall Redness of Inflammatory Lesions - Week 12 [ Time Frame: 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
38. Overall Size of Inflammatory Lesions - Week 1 [ Time Frame: 1 week ]
    Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
39. Overall Size of Inflammatory Lesions - Week 2 [ Time Frame: 2 weeks ]
    Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
40. Overall Size of Inflammatory Lesions - Week 4 [ Time Frame: 4 weeks ]
    Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
41. Overall Size of Inflammatory Lesions - Week 8 [ Time Frame: 8 weeks ]
    Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.
42. Overall Size of Inflammatory Lesions - Week 12 [ Time Frame: 12 weeks ]
    Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New Mexico

Academic Dermatology Associates

Albuquerque, New Mexico, United States, 87106

United States, Texas

Thomas J. Stephens and Associates, Inc.

Richardson, Texas, United States, 75081

Sponsors and Collaborators

Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

• Principal Investigator: Alicia Bucko, D.O.; Academic Dermatology Associates
• Principal Investigator: Lily Jiang, Ph.D.; Thomas J. Stephens & Associates, Inc.

  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):

Statistical Analysis Plan  [PDF] October 19, 2017

Study Protocol  [PDF] March 6, 2017

More Information

Publications:

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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. Erratum In: Phys Med Biol. 2013 Jul 21;58(14):5007-8.

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.

• Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
• ClinicalTrials.gov Identifier: NCT03124381
• Other Study ID Numbers: PS-170103145529-SACT
• First Posted: April 21, 2017
• Results First Posted: November 9, 2018
• Last Update Posted: February 15, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):

Acne

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases