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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) )

Tracking Information
First Submitted Date  ICMJE April 3, 2017
First Posted Date  ICMJE April 21, 2017
Results First Submitted Date  ICMJE September 4, 2018
Results First Posted Date  ICMJE November 9, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE April 8, 2017
Actual Primary Completion Date September 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03124381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • Global Face Open Comedones Count - Week 2 [ Time Frame: 2 weeks ]
    Open comedones count on global face - Week 2
  • Global Face Open Comedones Count - Week 4 [ Time Frame: 4 weeks ]
    Open comedones count on global face - Week 4
  • Global Face Open Comedones Count - Week 8 [ Time Frame: 8 weeks ]
    Open comedones count on global face - Week 8
  • Global Face Open Comedones Count - Week 12 [ Time Frame: 12 weeks ]
    Open comedones count on global face - Week 12
  • Global Face Closed Comedones Count - Week 2 [ Time Frame: 2 weeks ]
    Closed comedones count on global face - Week 2
  • Global Face Closed Comedones Count - Week 4 [ Time Frame: 4 weeks ]
    Closed comedones count on global face - Week 4
  • Global Face Closed Comedones Count - Week 8 [ Time Frame: 8 weeks ]
    Closed comedones count on global face - Week 8
  • Global Face Closed Comedones Count - Week 12 [ Time Frame: 12 weeks ]
    Closed comedones count on global face - Week 12
  • Global Face Inflammatory Lesion Count - Week 2 [ Time Frame: 2 weeks ]
    Papules and pustules counted together
  • Global Face Inflammatory Lesion Count - Week 4 [ Time Frame: 4 weeks ]
    Papules and pustules counted together
  • Global Face Inflammatory Lesion Count - Week 8 [ Time Frame: 8 weeks ]
    Papules and pustules counted together
  • Global Face Inflammatory Lesion Count - Week 12 [ Time Frame: 12 weeks ]
    Papules and pustules counted together
  • Global Face Non-Inflammatory Lesion Count - Week 2 [ Time Frame: 2 weeks ]
    Sum of open comedones and closed comedones
  • Global Face Non-Inflammatory Lesion Count - Week 4 [ Time Frame: 4 weeks ]
    Sum of open comedones and closed comedones
  • Global Face Non-Inflammatory Lesion Count - Week 8 [ Time Frame: 8 weeks ]
    Sum of open comedones and closed comedones
  • Global Face Non-Inflammatory Lesion Count - Week 12 [ Time Frame: 12 weeks ]
    Sum of open comedones and closed comedones
  • Global Face Total Lesion Count - Week 2 [ Time Frame: 2 weeks ]
    Sum of inflammatory and non-inflammatory lesions
  • Global Face Total Lesion Count - Week 4 [ Time Frame: 4 weeks ]
    Sum of inflammatory and non-inflammatory lesions
  • Global Face Total Lesion Count - Week 8 [ Time Frame: 8 weeks ]
    Sum of inflammatory and non-inflammatory lesions
  • Global Face Total Lesion Count - Week 12 [ Time Frame: 12 weeks ]
    Sum of inflammatory and non-inflammatory lesions
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Evaluator-blind
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Acne Mask
    Cleanser, Acne Mask
    Intervention: Device: Cleanser, Acne Mask
  • Experimental: Gel-Cream + Acne Mask
    Cleanser, Gel-Cream, Acne Mask
    Intervention: Device: Cleanser, Gel-Cream, Acne Mask
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2018)
126
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 6, 2017
Actual Primary Completion Date September 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03124381
Other Study ID Numbers  ICMJE PS-170103145529-SACT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
Study Sponsor  ICMJE Johnson & Johnson Consumer Inc. (J&JCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alicia Bucko, D.O. Academic Dermatology Associates
Principal Investigator: Lily Jiang, Ph.D. Thomas J. Stephens & Associates, Inc.
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP