Acne VulgarisTIGERNCT02698436
A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne.
A study testing Acne Mask and 2.5% Benzoyl Peroxide Treatment in people with Acne Vulgaris, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Acne Mask and 2.5% Benzoyl Peroxide Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2016to 31 Aug 2016
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Acne Mask, 2.5% Benzoyl Peroxide Treatment
- 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 Device
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
2.5% Benzoyl Peroxide TreatmentDrug
Also called BPO
The BPO treatment is applied twice daily, once in the morning and once in the evening
| Study group | Role | What they receive |
|---|---|---|
| Acne Mask | Experimental | 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 Receives: Device: Acne Mask |
| 2.5% Benzoyl Peroxide Treatment | Active comparator | 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 Receives: Drug: 2.5% Benzoyl Peroxide Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change of Global Face Total Acne Lesion Count From Baseline
Measured: Baseline to 12 Weeks
Secondary outcomes (16)
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1
Measured: Baseline to 1 Week
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2
Measured: Baseline to 2 Weeks
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4
Measured: Baseline to 4 Weeks
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8
Measured: Baseline to 8 Weeks
Acne Lesion Counts Total Global Face - Baseline
Acne Lesion Count Total Global Face at Baseline
Measured: Baseline
Acne Lesion Counts Total Global Face - Week 1
Acne Lesion Count Total Global Face Week 1
Measured: 1 Week
Acne Lesion Counts Total Global Face - Week 2
Acne Lesion Count Total Global Face Week 2
Measured: 2 Weeks
Acne Lesion Counts Total Global Face - Week 4
Acne Lesion Count Total Global Face Week 4
Measured: 4 Weeks
Acne Lesion Counts Total Global Face - Week 8
Acne Lesion Count Total Global Face Week 8
Measured: 8 Weeks
Acne Lesion Counts Total Global Face - Week 12
Acne Lesion Count Total Global Face Week 12
Measured: 12 Weeks
Investigator Global Acne Assessment - 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.
- Almost Clear. A few scattered comedones and a few (less than five) small papules.
- Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
- Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
- Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
- Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Measured: Baseline
Investigator Global Acne Assessment - Week 1
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.
- Almost Clear. A few scattered comedones and a few (less than five) small papules.
- Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
- Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
- Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
- Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Measured: 1 Week
Investigator Global Acne Assessment - Week 2
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.
- Almost Clear. A few scattered comedones and a few (less than five) small papules.
- Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
- Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
- Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
- Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Measured: 2 Weeks
Investigator Global Acne Assessment - Week 4
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.
- Almost Clear. A few scattered comedones and a few (less than five) small papules.
- Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
- Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
- Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
- Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Measured: 4 Weeks
Investigator Global Acne Assessment - Week 8
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.
- Almost Clear. A few scattered comedones and a few (less than five) small papules.
- Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
- Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
- Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
- Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Measured: 8 Weeks
Investigator Global Acne Assessment - Week 12
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.
- Almost Clear. A few scattered comedones and a few (less than five) small papules.
- Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.
- Moderate More than half of the face is involved. Numerous comedones, papules and pustules.
- Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.
- Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
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 posted3 Mar 2016 (estimated)
- Study start31 Mar 2016
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicia D Bucko, D.O., Principal investigator, Academic Dermatology AssociatesLily Jiang, Ph.D., Principal investigator, Thomas J. Stephens and Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698436
- Sponsor's protocol ID
- CO-151211140520-SACT
- Acronym
- TIGER
- Status last verified
- Dec 2017
- First submitted
- 26 Feb 2016
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 12589953Kjeldstad 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 6730638Barolet 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. 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 Treatments on Subjects With Mild to Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02698436
- Acronym / sponsor ID
- TIGER / CO-151211140520-SACT
- Conditions
- Acne Vulgaris
- Keywords
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acne Mask | Experimental | Device: Acne MaskThe 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 |
| 2.5% Benzoyl Peroxide Treatment | Active comparator | Drug: 2.5% Benzoyl Peroxide TreatmentCleanser 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 |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 DeviceThe 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 | Device | Acne Mask |
| 2.5% Benzoyl Peroxide TreatmentAlso: BPOThe BPO treatment is applied twice daily, once in the morning and once in the evening | Drug | 2.5% Benzoyl Peroxide Treatment |
Primary outcome
Percent Change of Global Face Total Acne Lesion Count From Baseline
Time frame: Baseline to 12 Weeks
16 secondary outcomes
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 Counts Total Global Face - Week 1
Time frame: 1 Week
Acne Lesion Counts Total Global Face - Week 2
Time frame: 2 Weeks
Acne Lesion Counts Total Global Face - Week 4
Time frame: 4 Weeks
Acne Lesion Counts Total Global Face - Week 8
Time frame: 8 Weeks
Acne Lesion Counts Total Global Face - Week 12
Time frame: 12 Weeks
Investigator Global Acne Assessment - Baseline
Time frame: Baseline
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- 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 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.
- 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 D Bucko, D.O. principal investigator
Academic Dermatology Associates
Lily Jiang, Ph.D. principal investigator
Thomas J. Stephens and 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 Acne Mask and 2.5% Benzoyl Peroxide Treatment in people with Acne Vulgaris, run by Johnson & Johnson Consumer and Personal Products Worldwide 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 7 inclusion and 5 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 23 Jan 2018. 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 23 Jan 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?
Percent Change of Global Face Total Acne Lesion Count From Baseline (time frame: Baseline to 12 Weeks). 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 NCT02698436, 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 23 Jan 2018.