Acne VulgarisNCT03128723

A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris

A study testing Acne Mask in people with Acne Vulgaris, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will look to evaluate the tolerance of a light therapy-based acne mask device in participants who report having sensitive skin. All participants will receive a cleanser, a light therapy mask, and an extra activator for the light therapy mask. Read more about this study

Who is it for?: Ages 12 to 40 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Acne Mask
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 30 Apr 2017to 8 Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

In good general health
Has mild to moderate facial acne
Has sensitive skin per sensitive skin questionnaires
Has score of "0" or "1" in all tolerance parameters (erythema, dryness/scaling, edema, burning/stinging, itching, and tightness/dryness feeling)
Able to read, write, speak, and understand English
Must agree to practice a medically acceptable form of birth control

Who cannot join

Has known light or photo-sensitivity disorder
Has very sensitive skin or known allergies to skincare products or the cleanser ingredients
Has severe acne or pre-existing facial skin conditions other than mild to moderate acne
Females that are pregnant, nursing, or planning to become pregnant
Males with a female partner who is pregnant or planning to become pregnant
Has been using a product or medication that the investigator determines will increase health risk to the subject or confuse the study results

Show all 10Show fewer

Is participating or has participated in another study with the past 30 days
Has history of immunosuppression/immune deficiency disorders
Has planned surgeries or invasive medical procedures scheduled during the study
Is related to the Sponsor, Investigator, or Study Site

Trial locations and contacts

1 site in 1 country.

United States1 site

Tennessee Clinical Research Center
Nashville, Tennessee, 37215

Other trials in United States

About this study

Official title: A Single Center Clinical Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris

Read the detailed description

Acne and sensitive skin can be closely connected due to the reported involvement of an impaired skin barrier in both conditions, which can be further aggravated by potentially irritating topical treatments.

A patient's sensitive skin may be caused by the skincare products that they are using, the amount that they are applying (over-usage), or the concomitant effect of the different products being used, as well as by underlying medical conditions. While sensitive skin can be self-perceived and sometimes clinically apparent, as there is no agreed upon medical definition of 'sensitive skin', it is a 'diagnosis' primarily made by the patient's perception. The high incidence of this problem and potential for further irritation due to current topical treatments has left many patients in need of a sensitive skin solution for their acne.

Current at-home topical treatments for mild to moderate acne include Over-the-Counter (OTC) options, primarily with either benzoyl peroxide, or salicylic acid, as well as prescription options including retinoid-based products, however the cutaneous irritation potential of topical acne active ingredients has been reported in the literature, which is not desirable in particular for patients with sensitive skin.

Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with blue light reported to target acne-causing bacteria and red light demonstrating anti-inflammatory activity. Previous studies with these types of modalities have shown high tolerance and efficacy. This study will look to evaluate the tolerance of a light therapy-based medical device in patients with self-reported sensitive skin.

Conditions: Acne Vulgaris
Being tested: Acne Mask
Keywords: Acne
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acne MaskDevice
Also called Light Therapy Acne Mask
The light therapy acne mask 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.

Study groups in NCT03128723
Study group	Role	What they receive
Acne Mask	Experimental	The light therapy acne mask 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. Receives: Device: Acne Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

Cutaneous Tolerance Scores: Erythema
Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 28. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.
Measured: Baseline to Day 28
Cutaneous Tolerance Scores: Dryness/Scaling
Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 28. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.
Measured: Baseline to Day 28
Cutaneous Tolerance Scores: Edema
Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 28. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.
Measured: Baseline to Day 28
Cutaneous Tolerance Scores: Burning/Stinging
Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 28. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.
Measured: Baseline to Day 28
Cutaneous Tolerance Scores: Itching
Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 28. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.
Measured: Baseline to Day 28
Cutaneous Tolerance Scores: Tightness/Dry Feeling
Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 28. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.
Measured: Baseline to Day 28

Secondary outcomes (6)

Cutaneous Tolerance Scores: Erythema
Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 14. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.
Measured: Baseline to Day 14
Cutaneous Tolerance Scores: Dryness/Scaling
Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 14. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.
Measured: Baseline to Day 14
Cutaneous Tolerance Scores: Edema
Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 14. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.
Measured: Baseline to Day 14
Cutaneous Tolerance Scores: Burning/Stinging
Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 14. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.
Measured: Baseline to Day 14
Cutaneous Tolerance Scores: Itching
Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 14. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.
Measured: Baseline to Day 14
Cutaneous Tolerance Scores: Tightness/Dry
Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 14. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.
Measured: Baseline to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 20178 Jun 2017

First posted25 Apr 2017
Study start30 Apr 2017
Primary completion8 Jun 2017
Study completion8 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03128723
Sponsor's protocol ID: CO-170125113728-SACT
Status last verified: Aug 2018
First submitted: 20 Apr 2017
Last updated: 31 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Muizzuddin N, Marenus KD, Maes DH. Factors defining sensitive skin and its treatment. Am J Contact Dermat. 1998 Sep;9(3):170-5.
PubMed 9744910
Willis CM, Shaw S, De Lacharriere O, Baverel M, Reiche L, Jourdain R, Bastien P, Wilkinson JD. Sensitive skin: an epidemiological study. Br J Dermatol. 2001 Aug;145(2):258-63. doi: 10.1046/j.1365-2133.2001.04343.x.
PubMed 11531788
Sagransky M, Yentzer BA, Feldman SR. Benzoyl peroxide: a review of its current use in the treatment of acne vulgaris. Expert Opin Pharmacother. 2009 Oct;10(15):2555-62. doi: 10.1517/14656560903277228.
PubMed 19761357

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center Clinical Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris
ClinicalTrials.gov ID: NCT03128723
Acronym / sponsor ID: CO-170125113728-SACT
Conditions: Acne Vulgaris
Keywords: Acne
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 30 Apr 2017 (actual)
Primary completion: 8 Jun 2017 (actual)
Study completion: 8 Jun 2017 (actual)
First posted: 25 Apr 2017 (actual)
Results: Posted 31 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Acne Mask	Experimental	Device: Acne MaskThe light therapy acne mask 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.

Who may qualify

Ages: 12 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

In good general health
Has mild to moderate facial acne
Has sensitive skin per sensitive skin questionnaires
Has score of "0" or "1" in all tolerance parameters (erythema, dryness/scaling, edema, burning/stinging, itching, and tightness/dryness feeling)
Able to read, write, speak, and understand English

Key exclusion criteria (10 listed)

Has known light or photo-sensitivity disorder
Has very sensitive skin or known allergies to skincare products or the cleanser ingredients
Has severe acne or pre-existing facial skin conditions other than mild to moderate acne
Females that are pregnant, nursing, or planning to become pregnant
Males with a female partner who is pregnant or planning to become pregnant

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
Acne MaskAlso: Light Therapy Acne MaskThe light therapy acne mask 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.	Device	Acne Mask

Primary outcome

Cutaneous Tolerance Scores: Erythema
Time frame: Baseline to Day 28
Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 28. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.
Cutaneous Tolerance Scores: Dryness/Scaling
Time frame: Baseline to Day 28
Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 28. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.
Cutaneous Tolerance Scores: Edema
Time frame: Baseline to Day 28
Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 28. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.
Cutaneous Tolerance Scores: Burning/Stinging
Time frame: Baseline to Day 28
Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 28. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.
Cutaneous Tolerance Scores: Itching
Time frame: Baseline to Day 28
Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 28. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.
Cutaneous Tolerance Scores: Tightness/Dry Feeling
Time frame: Baseline to Day 28
Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 28. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.

6 secondary outcomes

Cutaneous Tolerance Scores: Erythema
Time frame: Baseline to Day 14
Cutaneous Tolerance Scores: Dryness/Scaling
Time frame: Baseline to Day 14
Cutaneous Tolerance Scores: Edema
Time frame: Baseline to Day 14
Cutaneous Tolerance Scores: Burning/Stinging
Time frame: Baseline to Day 14
Cutaneous Tolerance Scores: Itching
Time frame: Baseline to Day 14
Cutaneous Tolerance Scores: Tightness/Dry
Time frame: Baseline to Day 14

Results and safety

Results posted to the registry on 31 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acne Mask	45	43

Primary outcome: Cutaneous Tolerance Scores: Erythema

Time frame: Baseline to Day 28. Mean (Standard Deviation). Unit: Units on a scale

Measure	Acne Mask n = 43
Value	-0.07 (0.34)

Primary outcome: Cutaneous Tolerance Scores: Dryness/Scaling

Time frame: Baseline to Day 28. Mean (Standard Deviation). Unit: Units on a scale

Measure	Acne Mask n = 43
Value	-0.14 (0.41)

Primary outcome: Cutaneous Tolerance Scores: Edema

Time frame: Baseline to Day 28. Mean (Standard Deviation). Unit: Units on a scale

Measure	Acne Mask n = 43
Value	0.00 (0.00)

Primary outcome: Cutaneous Tolerance Scores: Burning/Stinging

Time frame: Baseline to Day 28. Mean (Standard Deviation). Unit: Units on a scale

Measure	Acne Mask n = 43
Value	0.00 (0.00)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported from the time a signed and dated informed consent was obtained at Baseline until Day 28 or subject's last visit. Serious adverse events were also reportable within 30 calendar days of subject's last visit. Spontaneously reported seriously adverse events after the 30 calendar days period assessed by the investigator to be study related would be reportable to the Sponsor.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acne Mask	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9744910Muizzuddin N, Marenus KD, Maes DH. Factors defining sensitive skin and its treatment. Am J Contact Dermat. 1998 Sep;9(3):170-5.
Background: PubMed 11531788Willis CM, Shaw S, De Lacharriere O, Baverel M, Reiche L, Jourdain R, Bastien P, Wilkinson JD. Sensitive skin: an epidemiological study. Br J Dermatol. 2001 Aug;145(2):258-63. doi: 10.1046/j.1365-2133.2001.04343.x.
Background: PubMed 19761357Sagransky M, Yentzer BA, Feldman SR. Benzoyl peroxide: a review of its current use in the treatment of acne vulgaris. Expert Opin Pharmacother. 2009 Oct;10(15):2555-62. doi: 10.1517/14656560903277228.
Individual participant dataSharing planned: No

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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.

Michael H Gold, M.D. principal investigator

Tennessee Clinical Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acne Mask in people with Acne Vulgaris, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

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 10 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: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cutaneous Tolerance Scores: Erythema (time frame: Baseline to Day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03128723, which also lists 3 linked publications.

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 31 Aug 2018.