Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acne Mask | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 14 |
| Cutaneous Tolerance Scores: Dryness/Scaling |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael H Gold, M.D. | Tennessee Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9744910 | Background | Muizzuddin N, Marenus KD, Maes DH. Factors defining sensitive skin and its treatment. Am J Contact Dermat. 1998 Sep;9(3):170-5. | |
| 11531788 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment Period: April 04, 2017, to May 10, 2017.
Location: Clinical site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acne Mask | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acne Mask | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 28 |
|
|
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.
The investigator or a designee interviewed subjects for changes in health/medication at each visit, documenting any reported adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acne Mask | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gboyega Adenaike | JnJ Worldwide | 908-874-1214 | aadenaike@its.jnj.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2018 | Jun 6, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline to Day 28 |
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. |
| 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. | 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. | 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. | 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. | Baseline to Day 14 |
| 19761357 | Background | 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. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fitzpatrick skin type | Fitzpatrick skin type range I to VI: I: White; very fair; red or blonde hair; blue eyes; freckles; Always burns easily; never tans II: White; fair; red or blonde hair; blue hazel, or green eyes; Always burns easily; tans minimally III: Cream white; fair with any eye or hair color; very common; Burns moderately; tans gradually IV: Brown; typical Mediterranean white skin; Burns minimally; always tans well V: Dark brown; mid-eastern skin types, black hair, olive skin; Rarely burns; tans profusely VI: Black; black hair, black eyes, black skin; Never burns; deeply pigmented | Count of Participants | Participants |
|
| Investigator's global acne assessment | Investigator's global acne assessment score 0-4 | Count of Participants | Participants |
|
| Do you consider your facial skin to be sensitive? | Count of Participants | Participants |
|
| In the past, have you ever experienced skin irritation when using topical acne treatments? | Count of Participants | Participants |
|
| In the past, have you ever stopped using a topical acne treatment due to skin irritation | Count of Participants | Participants |
|
| Have you ever been told by a skin care professional that you have sensitive skin on your face? | Count of Participants | Participants |
|
| When purchasing skincare products, do you look for products labeled "for sensitive skin" or similar? | Count of Participants | Participants |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 14 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 14 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 14 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 14 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Units on a scale | Baseline to Day 14 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Units on a scale | Baseline to Day 14 |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
Prior to submission for any public disclosure of the data or results, the PI will provide the Sponsor with at least 60 days for review of the publication. Sponsor's written consent is required for any publication containing the Sponsor's confidential information. The Sponsor may request that the PI withholds such publication for up to an additional 60 days to allow for filing of a patent application.