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

February 13, 2019 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • Texas
      • Richardson, Texas, United States, 75081
        • Thomas J. Stephens and Associates, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 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
Baseline and 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
Baseline and 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.
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
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.
Baseline to Week 2 and Week 4
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.
Baseline to Week 4 and Week 8
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.
Baseline to Week 8 and Week 12
Global Face Open Comedones Count - Week 2
Time Frame: 2 weeks
Open comedones count on global face - Week 2
2 weeks
Global Face Open Comedones Count - Week 4
Time Frame: 4 weeks
Open comedones count on global face - Week 4
4 weeks
Global Face Open Comedones Count - Week 8
Time Frame: 8 weeks
Open comedones count on global face - Week 8
8 weeks
Global Face Open Comedones Count - Week 12
Time Frame: 12 weeks
Open comedones count on global face - Week 12
12 weeks
Global Face Closed Comedones Count - Week 2
Time Frame: 2 weeks
Closed comedones count on global face - Week 2
2 weeks
Global Face Closed Comedones Count - Week 4
Time Frame: 4 weeks
Closed comedones count on global face - Week 4
4 weeks
Global Face Closed Comedones Count - Week 8
Time Frame: 8 weeks
Closed comedones count on global face - Week 8
8 weeks
Global Face Closed Comedones Count - Week 12
Time Frame: 12 weeks
Closed comedones count on global face - Week 12
12 weeks
Global Face Inflammatory Lesion Count - Week 2
Time Frame: 2 weeks
Papules and pustules counted together
2 weeks
Global Face Inflammatory Lesion Count - Week 4
Time Frame: 4 weeks
Papules and pustules counted together
4 weeks
Global Face Inflammatory Lesion Count - Week 8
Time Frame: 8 weeks
Papules and pustules counted together
8 weeks
Global Face Inflammatory Lesion Count - Week 12
Time Frame: 12 weeks
Papules and pustules counted together
12 weeks
Global Face Non-Inflammatory Lesion Count - Week 2
Time Frame: 2 weeks
Sum of open comedones and closed comedones
2 weeks
Global Face Non-Inflammatory Lesion Count - Week 4
Time Frame: 4 weeks
Sum of open comedones and closed comedones
4 weeks
Global Face Non-Inflammatory Lesion Count - Week 8
Time Frame: 8 weeks
Sum of open comedones and closed comedones
8 weeks
Global Face Non-Inflammatory Lesion Count - Week 12
Time Frame: 12 weeks
Sum of open comedones and closed comedones
12 weeks
Global Face Total Lesion Count - Week 2
Time Frame: 2 weeks
Sum of inflammatory and non-inflammatory lesions
2 weeks
Global Face Total Lesion Count - Week 4
Time Frame: 4 weeks
Sum of inflammatory and non-inflammatory lesions
4 weeks
Global Face Total Lesion Count - Week 8
Time Frame: 8 weeks
Sum of inflammatory and non-inflammatory lesions
8 weeks
Global Face Total Lesion Count - Week 12
Time Frame: 12 weeks
Sum of inflammatory and non-inflammatory lesions
12 weeks
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.
1 week
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.
2 weeks
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.
4 weeks
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.
8 weeks
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.
12 weeks
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
1 week
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
2 weeks
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
4 weeks
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
8 weeks
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
12 weeks
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
1 week
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
2 weeks
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
4 weeks
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.
8 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lily Jiang, Ph.D., Thomas J. Stephens & Associates, Inc.
  • Principal Investigator: Alicia Bucko, D.O., Academic Dermatology Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PS-170103145529-SACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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