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A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne. (TIGER)

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ClinicalTrials.gov Identifier: NCT02698436
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Tracking Information
First Submitted Date  ICMJE February 26, 2016
First Posted Date  ICMJE March 3, 2016
Results First Submitted Date  ICMJE August 29, 2017
Results First Posted Date  ICMJE January 23, 2018
Last Update Posted Date January 23, 2018
Actual Study Start Date  ICMJE March 31, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
Percent Change of Global Face Total Acne Lesion Count From Baseline [ Time Frame: Baseline to 12 Weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02698436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
  • Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1 [ Time Frame: Baseline to 1 Week ]
  • Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2 [ Time Frame: Baseline to 2 Weeks ]
  • Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4 [ Time Frame: Baseline to 4 Weeks ]
  • Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8 [ Time Frame: Baseline to 8 Weeks ]
  • Acne Lesion Counts Total Global Face - Baseline [ Time Frame: Baseline ]
    Acne Lesion Count Total Global Face at Baseline
  • Acne Lesion Counts Total Global Face - Week 1 [ Time Frame: 1 Week ]
    Acne Lesion Count Total Global Face Week 1
  • Acne Lesion Counts Total Global Face - Week 2 [ Time Frame: 2 Weeks ]
    Acne Lesion Count Total Global Face Week 2
  • Acne Lesion Counts Total Global Face - Week 4 [ Time Frame: 4 Weeks ]
    Acne Lesion Count Total Global Face Week 4
  • Acne Lesion Counts Total Global Face - Week 8 [ Time Frame: 8 Weeks ]
    Acne Lesion Count Total Global Face Week 8
  • Acne Lesion Counts Total Global Face - Week 12 [ Time Frame: 12 Weeks ]
    Acne Lesion Count Total Global Face Week 12
  • Investigator Global Acne Assessment - Baseline [ Time Frame: Baseline ]
    Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present.
    1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
    2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
    3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
    4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
    5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
  • Investigator Global Acne Assessment - Week 1 [ Time Frame: 1 Week ]
    Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present.
    1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
    2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
    3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
    4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
    5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
  • Investigator Global Acne Assessment - Week 2 [ Time Frame: 2 Weeks ]
    Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present.
    1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
    2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
    3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
    4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
    5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
  • Investigator Global Acne Assessment - Week 4 [ Time Frame: 4 Weeks ]
    Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present.
    1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
    2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
    3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
    4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
    5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
  • Investigator Global Acne Assessment - Week 8 [ Time Frame: 8 Weeks ]
    Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present.
    1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
    2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
    3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
    4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
    5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
  • Investigator Global Acne Assessment - Week 12 [ Time Frame: 12 Weeks ]
    Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present.
    1. Almost Clear. A few scattered comedones and a few (less than five) small papules.
    2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
    3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
    4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
    5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
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 Effectiveness and Tolerance of Two Acne Treatments 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 Treatments on Subjects With Mild to Moderate Acne Vulgaris
Brief Summary This study will compare two different acne treatments for the treatment of acne. Half of the participants will receive two marketed acne products (cleanser and leave-on topical treatment), while the other half of the participants will receive a marketed cleanser and a light-therapy device.
Detailed Description

Acne is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompanying sebaceous gland.

Benzoyl peroxide (BPO) is one of the most effective and well-studied over-the-counter (OTC) acne therapies, is generally regarded as safe and effective and is considered as a first-line treatment for acne. Topical BPO monotherapy products for at-home acne treatment have been available for OTC use for more than 30 years and studies have indicated that a low dose of BPO may be an effective approach for treating acne using an OTC product when applied consistently to larger areas of the face due primarily to its effects against acne-causing bacteria.

BPO has anti-inflammatory and keratolytic properties, but is thought to act primarily to control P. acnes by releasing reactive oxygen species that are toxic to the bacteria. The most common side effect of topical BPO treatment is skin irritation, which can include erythema, burning, and peeling.

As an alternative to topical OTC standard of care therapies, research has also 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 the acne-causing bacteria and have an effect on inflammation reduction.

Light-based therapies have been successfully used to treat dermatological conditions since the early 1900's, with various parts of the electromagnetic spectrum (i.e. 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 Food and Drug Administration and has been approved for use in humans.

This study will look to compare the acne clearing efficacy and tolerance of two different acne treatments: a currently marketed 2.5% BPO full-face topical OTC treatment, and an Investigational red and blue light acne light therapy mask, to determine if the acne resolution efficacy of the Investigational mask is as effective as a current OTC standard of care for at-home treatment of mild to moderate acne.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Device: Acne Mask
    The light therapy device contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes
    Other Name: Light-Therapy Acne Device
  • Drug: 2.5% Benzoyl Peroxide Treatment
    The BPO treatment is applied twice daily, once in the morning and once in the evening
    Other Name: BPO
Study Arms  ICMJE
  • Experimental: Acne Mask

    The light therapy acne device is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.

    Other Names: Cleanser is marketed while the device is not marketed

    Intervention: Device: Acne Mask
  • Active Comparator: 2.5% Benzoyl Peroxide Treatment

    Cleanser and 2.5% Benzoyl Peroxide Treatment Both the cleanser and the 2.5% Benzoyl Peroxide Treatment are applied twice daily, once in the morning and once in the evening.

    Other names: Both products are marketed

    Intervention: Drug: 2.5% Benzoyl Peroxide Treatment
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: April 12, 2017)
103
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 31, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has mild to moderate acne
  • Has 10 - 100 pimples, 10 - 50 inflamed red pimples, up to 2 raised bumps and no cysts
  • In general good health
  • Must avoid excessive sun exposure and any light treatments or any professional or aesthetic spa-like procedures
  • Must not be pregnant, nursing or intend to become pregnant during the study
  • Must agree to practice a medically acceptable form of birth control.
  • Must be able to read, speak, write and understand English

Exclusion Criteria:

  • Allergies or sensitivities to product ingredients or to light
  • Has severe acne or pre-existing dermatological facial condition
  • Has an uncontrolled disease or immune deficient disorder
  • Is pregnant, breast-feeding or intending to become pregnant
  • Has been taking prescription drug medication for acne or antibiotics for the past 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02698436
Other Study ID Numbers  ICMJE CO-151211140520-SACT
Has Data Monitoring Committee Yes
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: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide
Study Sponsor  ICMJE Johnson & Johnson Consumer and Personal Products Worldwide
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alicia D Bucko, D.O. Academic Dermatology Associates
Principal Investigator: Lily Jiang, Ph.D. Thomas J. Stephens and Associates, Inc.
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date December 2017

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