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Low recruiting rate
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Up to 20 healthy subjects age 15-45 years old ,Skin Phototype I-V,Study will be conducted in 1 site.
Primary objectives is to evaluate the efficacy of IPL acne filter treatment for improvement of acne vulgaris as assessed by lesion count.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acne Treatment | Experimental | Acne treatment using the M22-IPL acne filter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M22-IPL | Device | The M22 is an advanced computer-controlled light emission system that incorporates several different light modules. The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filter that will be used for this evaluation is the Acne Filter that cuts off all light with the wavelength of 400-600 and 800-1200nm. |
| Measure | Description | Time Frame |
|---|---|---|
| lesion count of acne vulgaris will be reduced by at least 50% for >75% of the study population. | The numbers of lesions are counted on each side of the face according to lesion type | week 6 (week 1 after the last treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Scale for Acne Vulgaris | The investigator will be required to grade the acne severity using the IGA scale | following the treatments: at Baseline ,5 weeks and at follow up 6 and 10 weeks. |
| Subject Discomfort Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. J. Matthew Knight, MD, FAAD | Knight Dermatology Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knight Dermatology Institute | Orlando | Florida | 32801 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain. |
| Following the treatments: Baseline,2,3,4,5 weeks |
| Long term side effect and adverse events | Any adverse events associated with various setting used during the treatment and follow-up period | throughout the duration of the study (Baseline,2,3,4,5 weeks) |
| Subject Downtime Evaluation | The downtime will be defined as the period of time following the procedure during which the subject had edema and erythema and felt unable/unwilling to go out in public | Following treatments baseline,2,3,4,5 weeks |
| Subject Satisfaction | The assessment will be based on a 5-point Likert scale detailed in Table 5 where 0 represents dissatisfied and 4 represents very satisfied. | week 4 ,6 ,10 |
| The Cardiff Acne Disability Index | The Cardiff Acne Disability Index is a short 5 item questionnaire derived from the longer Acne Disability Index | Baseline ,4,6,10 weeks |
| Subject personal experience | Subject's likelihood of recommending the treatment or seeking additional treatments recorded in a questionnaire using a six point scale: 1=Extremely Unlikely; 2=Very Unlikely; 3=Somewhat Unlikely; 4=Somewhat likely; 5=Very likely; 6=Extremely likely | week 10 |