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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( 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.

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124381


Locations
Layout table for location information
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
Layout table for investigator information
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


Publications:
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.
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.

Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT03124381     History of Changes
Other Study ID Numbers: PS-170103145529-SACT
First Posted: April 21, 2017    Key Record Dates
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

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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
Pediatric Postmarket Surveillance of a Device Product: No
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:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents