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. .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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.
Knight Dermatology Institute
Orlando, Florida, United States
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
Time frame: week 6 (week 1 after the last treatment)
Investigator Global Assessment (IGA) Scale for Acne Vulgaris
The investigator will be required to grade the acne severity using the IGA scale
Time frame: following the treatments: at Baseline ,5 weeks and at follow up 6 and 10 weeks.
Subject Discomfort Evaluation
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: week 4 ,6 ,10
The Cardiff Acne Disability Index
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The Cardiff Acne Disability Index is a short 5 item questionnaire derived from the longer Acne Disability Index
Time frame: 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
Time frame: week 10