Acne VulgarisNCT03124381

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

A study testing Cleanser, Acne Mask and Cleanser, Gel-Cream, Acne Mask in people with Acne Vulgaris, run by Johnson & Johnson Consumer Inc. (J&JCI) at 2 sites in United States.

Completed

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

Official record

Search all trials

Trial 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. 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?: Cleanser, Acne Mask and Cleanser, Gel-Cream, Acne Mask
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 2 sitesUnited States
Study dates: 8 Apr 2017to 6 Sep 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

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.

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Acne Vulgaris
Being tested: Cleanser, Acne Mask, Cleanser, Gel-Cream, 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.

Cleanser, Acne MaskDevice
Also called Light Therapy 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.
Cleanser, Gel-Cream, Acne MaskDevice
Also called Light Therapy Mask, Light Therapy Topical Gel-Cream
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.

Study groups in NCT03124381
Study group	Role	What they receive
Acne Mask	Active comparator	Cleanser, Acne Mask Receives: Device: Cleanser, Acne Mask
Gel-Cream + Acne Mask	Experimental	Cleanser, Gel-Cream, Acne Mask Receives: Device: Cleanser, Gel-Cream, Acne Mask

What is being measured

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

Global Face Total Lesion Count - Percent Change - Baseline to Week 12
Percent change from baseline in global face total lesion count at Week 12
Measured: Baseline and Week 12

Secondary outcomes (42)

Global Face Total Lesion Count - Percent Change - Baseline to Week 2
Percent change from baseline in global face total lesion count at Week 2
Measured: Baseline and Week 2
Global Face Total Lesion Count - Percent Change - Baseline to Week 4
Percent change from baseline in global face total lesion count at Week 4
Measured: Baseline and Week 4
Global Face Total Lesion Count - Percent Change - Baseline to Week 8
Percent change from baseline in global face total lesion count at Week 8
Measured: Baseline and Week 8
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits
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.
Measured: 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
Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated.
Measured: 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
Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated.
Measured: 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
Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated.
Measured: Baseline to Week 8 and Week 12
Global Face Open Comedones Count - Week 2
Open comedones count on global face - Week 2
Measured: 2 weeks
Global Face Open Comedones Count - Week 4
Open comedones count on global face - Week 4
Measured: 4 weeks
Global Face Open Comedones Count - Week 8
Open comedones count on global face - Week 8
Measured: 8 weeks
Global Face Open Comedones Count - Week 12
Open comedones count on global face - Week 12
Measured: 12 weeks
Global Face Closed Comedones Count - Week 2
Closed comedones count on global face - Week 2
Measured: 2 weeks
Global Face Closed Comedones Count - Week 4
Closed comedones count on global face - Week 4
Measured: 4 weeks
Global Face Closed Comedones Count - Week 8
Closed comedones count on global face - Week 8
Measured: 8 weeks
Global Face Closed Comedones Count - Week 12
Closed comedones count on global face - Week 12
Measured: 12 weeks
Global Face Inflammatory Lesion Count - Week 2
Papules and pustules counted together
Measured: 2 weeks
Global Face Inflammatory Lesion Count - Week 4
Papules and pustules counted together
Measured: 4 weeks
Global Face Inflammatory Lesion Count - Week 8
Papules and pustules counted together
Measured: 8 weeks
Global Face Inflammatory Lesion Count - Week 12
Papules and pustules counted together
Measured: 12 weeks
Global Face Non-Inflammatory Lesion Count - Week 2
Sum of open comedones and closed comedones
Measured: 2 weeks
Global Face Non-Inflammatory Lesion Count - Week 4
Sum of open comedones and closed comedones
Measured: 4 weeks
Global Face Non-Inflammatory Lesion Count - Week 8
Sum of open comedones and closed comedones
Measured: 8 weeks
Global Face Non-Inflammatory Lesion Count - Week 12
Sum of open comedones and closed comedones
Measured: 12 weeks
Global Face Total Lesion Count - Week 2
Sum of inflammatory and non-inflammatory lesions
Measured: 2 weeks
Global Face Total Lesion Count - Week 4
Sum of inflammatory and non-inflammatory lesions
Measured: 4 weeks
Global Face Total Lesion Count - Week 8
Sum of inflammatory and non-inflammatory lesions
Measured: 8 weeks
Global Face Total Lesion Count - Week 12
Sum of inflammatory and non-inflammatory lesions
Measured: 12 weeks
Investigator Global Acne Assessment - Week 1
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.
Measured: 1 week
Investigator Global Acne Assessment - Week 2
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.
Measured: 2 weeks
Investigator Global Acne Assessment - Week 4
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.
Measured: 4 weeks
Investigator Global Acne Assessment - Week 8
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.
Measured: 8 weeks
Investigator Global Acne Assessment - Week 12
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.
Measured: 12 weeks
Overall Redness of Inflammatory Lesions - Week 1
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
Measured: 1 week
Overall Redness of Inflammatory Lesions - Week 2
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
Measured: 2 weeks
Overall Redness of Inflammatory Lesions - Week 4
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
Measured: 4 weeks
Overall Redness of Inflammatory Lesions - Week 8
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
Measured: 8 weeks
Overall Redness of Inflammatory Lesions - Week 12
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
Measured: 12 weeks
Overall Size of Inflammatory Lesions - Week 1
Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Measured: 1 week
Overall Size of Inflammatory Lesions - Week 2
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Measured: 2 weeks
Overall Size of Inflammatory Lesions - Week 4
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Measured: 4 weeks
Overall Size of Inflammatory Lesions - Week 8
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.
Measured: 8 weeks
Overall Size of Inflammatory Lesions - Week 12
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Measured: 12 weeks

Timeline

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

8 Apr 20176 Sep 2017

First posted21 Apr 2017
Study start8 Apr 2017
Primary completion6 Sep 2017
Study completion6 Sep 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 (12)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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03124381
Sponsor's protocol ID: PS-170103145529-SACT
Status last verified: Feb 2019
First submitted: 3 Apr 2017
Last updated: 15 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. doi: 10.1111/j.1574-695X.2003.tb00644.x.
PubMed 12589953
Kjeldstad B. Photoinactivation of Propionibacterium acnes by near-ultraviolet light. Z Naturforsch C Biosci. 1984 Mar-Apr;39(3-4):300-2. doi: 10.1515/znc-1984-3-417.
PubMed 6730638
Roelandts R. A new light on Niels Finsen, a century after his Nobel Prize. Photodermatol Photoimmunol Photomed. 2005 Jun;21(3):115-7. doi: 10.1111/j.1600-0781.2005.00160.x. No abstract available.
PubMed 15888126
Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008 Dec;27(4):227-38. doi: 10.1016/j.sder.2008.08.003.
PubMed 19150294
Salomatina E, Jiang B, Novak J, Yaroslavsky AN. Optical properties of normal and cancerous human skin in the visible and near-infrared spectral range. J Biomed Opt. 2006 Nov-Dec;11(6):064026. doi: 10.1117/1.2398928.
PubMed 17212549
Bashkatov, AN, et al. Optical properties of melanin in the skin and skin-like phantoms. Proc. of SPIE, 4162: 219-226, 2000.
Bashkatov, AN, et al. Optical properties of human skin, subcutaneous and mucous tissues in the wavelength range from 400 to 2000 nm. J Phys D: Appl Phys, 38: 2543-2555, 2005.
Jacques SL. Optical properties of biological tissues: a review. Phys Med Biol. 2013 Jun 7;58(11):R37-61. doi: 10.1088/0031-9155/58/11/R37. Epub 2013 May 10.
PubMed 23666068
Lamouche G, Kennedy BF, Kennedy KM, Bisaillon CE, Curatolo A, Campbell G, Pazos V, Sampson DD. Review of tissue simulating phantoms with controllable optical, mechanical and structural properties for use in optical coherence tomography. Biomed Opt Express. 2012 Jun 1;3(6):1381-98. doi: 10.1364/BOE.3.001381. Epub 2012 May 15.
PubMed 22741083
Pogue BW, Patterson MS. Review of tissue simulating phantoms for optical spectroscopy, imaging and dosimetry. J Biomed Opt. 2006 Jul-Aug;11(4):041102. doi: 10.1117/1.2335429.
PubMed 16965130
Hirshburg J, Choi B, Nelson JS, Yeh AT. Correlation between collagen solubility and skin optical clearing using sugars. Lasers Surg Med. 2007 Feb;39(2):140-4. doi: 10.1002/lsm.20417.
PubMed 17311267
Wiegand, B, Luedtke, K, Rapp, SR. Acne Profile. Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933-7003, assignee. Patent US 2006/0008484 A1. 12 Jan. 2006. Print.

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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03124381
Acronym / sponsor ID: PS-170103145529-SACT
Conditions: Acne Vulgaris
Keywords: Acne
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 8 Apr 2017 (actual)
Primary completion: 6 Sep 2017 (actual)
Study completion: 6 Sep 2017 (actual)
First posted: 21 Apr 2017 (actual)
Results: Posted 9 Nov 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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Acne Mask	Active comparator	Device: Cleanser, Acne MaskCleanser, Acne Mask
Gel-Cream + Acne Mask	Experimental	Device: Cleanser, Gel-Cream, Acne MaskCleanser, Gel-Cream, Acne Mask

Who may qualify

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

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (11 listed)

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

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
Cleanser, Acne MaskAlso: Light Therapy MaskA 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.	Device	Acne Mask
Cleanser, Gel-Cream, Acne MaskAlso: Light Therapy Mask, Light Therapy Topical Gel-CreamA 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.	Device	Gel-Cream + Acne Mask

Primary outcome

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

42 secondary outcomes

Global Face Total Lesion Count - Percent Change - Baseline to Week 2
Time frame: Baseline and Week 2
Global Face Total Lesion Count - Percent Change - Baseline to Week 4
Time frame: Baseline and Week 4
Global Face Total Lesion Count - Percent Change - Baseline to Week 8
Time frame: 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 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 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 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 Open Comedones Count - Week 2
Time frame: 2 weeks
Global Face Open Comedones Count - Week 4
Time frame: 4 weeks
Global Face Open Comedones Count - Week 8
Time frame: 8 weeks
Global Face Open Comedones Count - Week 12
Time frame: 12 weeks
Global Face Closed Comedones Count - Week 2
Time frame: 2 weeks
Global Face Closed Comedones Count - Week 4
Time frame: 4 weeks
Global Face Closed Comedones Count - Week 8
Time frame: 8 weeks
Global Face Closed Comedones Count - Week 12
Time frame: 12 weeks
Global Face Inflammatory Lesion Count - Week 2
Time frame: 2 weeks
Global Face Inflammatory Lesion Count - Week 4
Time frame: 4 weeks
Global Face Inflammatory Lesion Count - Week 8
Time frame: 8 weeks
Global Face Inflammatory Lesion Count - Week 12
Time frame: 12 weeks
Global Face Non-Inflammatory Lesion Count - Week 2
Time frame: 2 weeks
Global Face Non-Inflammatory Lesion Count - Week 4
Time frame: 4 weeks
Global Face Non-Inflammatory Lesion Count - Week 8
Time frame: 8 weeks
Global Face Non-Inflammatory Lesion Count - Week 12
Time frame: 12 weeks
Global Face Total Lesion Count - Week 2
Time frame: 2 weeks
Global Face Total Lesion Count - Week 4
Time frame: 4 weeks
Global Face Total Lesion Count - Week 8
Time frame: 8 weeks
Global Face Total Lesion Count - Week 12
Time frame: 12 weeks
Investigator Global Acne Assessment - Week 1
Time frame: 1 week
Investigator Global Acne Assessment - Week 2
Time frame: 2 weeks
Investigator Global Acne Assessment - Week 4
Time frame: 4 weeks
Investigator Global Acne Assessment - Week 8
Time frame: 8 weeks
Investigator Global Acne Assessment - Week 12
Time frame: 12 weeks
Overall Redness of Inflammatory Lesions - Week 1
Time frame: 1 week
Overall Redness of Inflammatory Lesions - Week 2
Time frame: 2 weeks
Overall Redness of Inflammatory Lesions - Week 4
Time frame: 4 weeks
Overall Redness of Inflammatory Lesions - Week 8
Time frame: 8 weeks
Overall Redness of Inflammatory Lesions - Week 12
Time frame: 12 weeks
Overall Size of Inflammatory Lesions - Week 1
Time frame: 1 week
Overall Size of Inflammatory Lesions - Week 2
Time frame: 2 weeks
Overall Size of Inflammatory Lesions - Week 4
Time frame: 4 weeks

Results and safety

Results posted to the registry on 9 Nov 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
Gel-Cream + Acne Mask	65	56
Acne Mask	61	55

Primary outcome: Global Face Total Lesion Count - Percent Change - Baseline to Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: Percent Change in Lesions

Measure	Gel-Cream + Acne Mask n = 63	Acne Mask n = 60
Value	-42.64 (31.817)	-47.80 (30.209)

Gel-Cream + Acne Mask vs Acne Mask: Mean Difference (Net): 3.19 (95% CI -7.04 to 13.42)
Gel-Cream + Acne Mask vs Acne Mask: Mean Difference (Net): 3.19 (95% CI -7.04 to 13.42), p = 0.538, ANCOVA

Population analysed: Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. There was no post-baseline data to carry forward for three subjects.

42 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 12 unless terminated early). Serious adverse events (SAE) reported to the site were also reportable within 30 days of last procedure/visit and longer if considered study-related; there was no specific cut-off date for this reporting, but AEs/SAEs are shown in this posting for a collection period of 1 year from last subject's visit (the time of this posting).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gel-Cream + Acne Mask	0 of 65 (0%)	0 of 65 (0%)	0 of 65
Acne Mask	0 of 61 (0%)	0 of 61 (0%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12589953Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. doi: 10.1111/j.1574-695X.2003.tb00644.x.
Background: PubMed 6730638Kjeldstad B. Photoinactivation of Propionibacterium acnes by near-ultraviolet light. Z Naturforsch C Biosci. 1984 Mar-Apr;39(3-4):300-2. doi: 10.1515/znc-1984-3-417.
Background: PubMed 15888126Roelandts R. A new light on Niels Finsen, a century after his Nobel Prize. Photodermatol Photoimmunol Photomed. 2005 Jun;21(3):115-7. doi: 10.1111/j.1600-0781.2005.00160.x. No abstract available.
Background: PubMed 19150294Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008 Dec;27(4):227-38. doi: 10.1016/j.sder.2008.08.003.
Background: PubMed 17212549Salomatina E, Jiang B, Novak J, Yaroslavsky AN. Optical properties of normal and cancerous human skin in the visible and near-infrared spectral range. J Biomed Opt. 2006 Nov-Dec;11(6):064026. doi: 10.1117/1.2398928.
BackgroundBashkatov, AN, et al. Optical properties of melanin in the skin and skin-like phantoms. Proc. of SPIE, 4162: 219-226, 2000.
BackgroundBashkatov, AN, et al. Optical properties of human skin, subcutaneous and mucous tissues in the wavelength range from 400 to 2000 nm. J Phys D: Appl Phys, 38: 2543-2555, 2005.
Background: PubMed 23666068Jacques SL. Optical properties of biological tissues: a review. Phys Med Biol. 2013 Jun 7;58(11):R37-61. doi: 10.1088/0031-9155/58/11/R37. Epub 2013 May 10.
Background: PubMed 22741083Lamouche G, Kennedy BF, Kennedy KM, Bisaillon CE, Curatolo A, Campbell G, Pazos V, Sampson DD. Review of tissue simulating phantoms with controllable optical, mechanical and structural properties for use in optical coherence tomography. Biomed Opt Express. 2012 Jun 1;3(6):1381-98. doi: 10.1364/BOE.3.001381. Epub 2012 May 15.
Background: PubMed 16965130Pogue BW, Patterson MS. Review of tissue simulating phantoms for optical spectroscopy, imaging and dosimetry. J Biomed Opt. 2006 Jul-Aug;11(4):041102. doi: 10.1117/1.2335429.
Background: PubMed 17311267Hirshburg J, Choi B, Nelson JS, Yeh AT. Correlation between collagen solubility and skin optical clearing using sugars. Lasers Surg Med. 2007 Feb;39(2):140-4. doi: 10.1002/lsm.20417.
BackgroundWiegand, B, Luedtke, K, Rapp, SR. Acne Profile. Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933-7003, assignee. Patent US 2006/0008484 A1. 12 Jan. 2006. Print.
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.

Alicia Bucko, D.O. principal investigator

Academic Dermatology Associates

Lily Jiang, Ph.D. principal investigator

Thomas J. Stephens & Associates, Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing Cleanser, Acne Mask and Cleanser, Gel-Cream, Acne Mask in people with Acne Vulgaris, run by Johnson & Johnson Consumer Inc. (J&JCI) at 2 sites 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 11 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 9 Nov 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?

Global Face Total Lesion Count - Percent Change - Baseline to Week 12 (time frame: Baseline and Week 12). 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 NCT03124381, which also lists 12 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 15 Feb 2019.