AcneNCT03650881
The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne
A study testing Neutrogena ® Light Therapy Acne Mask (MASK) and Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene in people with Acne, run by NYU Langone Health.
Trial summary
This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of… Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Neutrogena ® Light Therapy Acne Mask (MASK) and Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2018to 5 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of acne vulgaris as determined by the study physician
- Mild-to-moderate acne defined as a grade 2 or 3 on the FDA Investigator Global Acne Assessment (IGA) for Acne vulgaris (Appendix 1)19
- If female,
- Negative urine pregnancy test at the time of enrollment and negative urine pregnancy tests at follow up visits
- Agreement to comply with medically acceptable forms of birth control with heterosexual intercourse
- Agreement to comply with the study protocol and attend all study visits
Who cannot join
- Is unwilling to participate in the survey
- Outside of specified age range
- Patients with clear, almost clear acne, or severe acne defined as grade 0-1 or 4 on the IGA Scale
- Females who are pregnant or breastfeeding
- Known allergy to any ingredients in the test products or history of photosensitivity
- Pre-existing facial dermatologic conditions including excoriations that could interfere with the outcome of this study and quantification of acne lesions
- Excessive facial hair or scarring that could interfere with quantification of acne lesions
- Does not have decision making capacity
About this study
This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.
- Conditions
- Acne
- Being tested
- Neutrogena ® Light Therapy Acne Mask (MASK), Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrogena ® Light Therapy Acne Mask (MASK)Drug
Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes
Topical OTC benzoyl peroxide 2.5% gel and OTC adapaleneDrug
Daily treatment with Reference Therapy OTC topical generic benzoyl peroxide 2.5% gel in the morning and OTC generic adapalene 0.1% gel at night
| Study group | Role | What they receive |
|---|---|---|
| Neutrogena ® Light Therapy Acne Mask (MASK) | Experimental | Over-the-counter powered light-based device for the treatment of acne Receives: Drug: Neutrogena ® Light Therapy Acne Mask (MASK) |
| Topical benzoyl peroxide 2.5% gel and OTC adapalene | Active comparator | Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel Receives: Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Investigator Global Assessment (IGA)
5 point assessment tool used to measure inflammation caused by acne
Measured: 12 Weeks
Secondary outcomes (1)
change in Acne Q4 quality of life index score
The Acne-QoL contains 19 questions organized into four domains (self-perception, role-social, roleemotional, and acne symptoms) which refer to facial acne. For all domains, higher scores reflect better HRQoL. The total score varies from zero to 114, distributed as follows: 0- 30 (self-perception), 0-24 (role-social), 0-30 (role-emotional), and 0-30 (acne symptoms).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start7 Aug 2018
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Why it stopped: no eligible subjects were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650881
- Sponsor's protocol ID
- 17-01725
- Status last verified
- May 2020
- First submitted
- 27 Aug 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne
- ClinicalTrials.gov ID
- NCT03650881
- Acronym / sponsor ID
- 17-01725
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no eligible subjects were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutrogena ® Light Therapy Acne Mask (MASK) | Experimental | Drug: Neutrogena ® Light Therapy Acne Mask (MASK)Over-the-counter powered light-based device for the treatment of acne |
| Topical benzoyl peroxide 2.5% gel and OTC adapalene | Active comparator | Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapaleneOver-the-counter medication for the treatment of acne + 0.1% Adepalene Gel |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of acne vulgaris as determined by the study physician
- Mild-to-moderate acne defined as a grade 2 or 3 on the FDA Investigator Global Acne Assessment (IGA) for Acne vulgaris (Appendix 1)19
- If female,
- Agreement to comply with the study protocol and attend all study visits
Key exclusion criteria (8 listed)
- Is unwilling to participate in the survey
- Outside of specified age range
- Patients with clear, almost clear acne, or severe acne defined as grade 0-1 or 4 on the IGA Scale
- Females who are pregnant or breastfeeding
- Known allergy to any ingredients in the test products or history of photosensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutrogena ® Light Therapy Acne Mask (MASK)Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes | Drug | Neutrogena ® Light Therapy Acne Mask (MASK) |
| Topical OTC benzoyl peroxide 2.5% gel and OTC adapaleneDaily treatment with Reference Therapy OTC topical generic benzoyl peroxide 2.5% gel in the morning and OTC generic adapalene 0.1% gel at night | Drug | Topical benzoyl peroxide 2.5% gel and OTC adapalene |
Primary outcome
change in the Investigator Global Assessment (IGA)
Time frame: 12 Weeks
5 point assessment tool used to measure inflammation caused by acne
1 secondary outcome
change in Acne Q4 quality of life index score
Time frame: 12 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
Related trials for Acne
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neutrogena ® Light Therapy Acne Mask (MASK) and Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene in people with Acne, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the Investigator Global Assessment (IGA) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.