Impact of the M22-IPL Acne Filter on Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT02180282|
Recruitment Status : Terminated (Low recruiting rate)
First Posted : July 2, 2014
Last Update Posted : January 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne||Device: M22-IPL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of the M22-IPL Acne Filter on Acne Vulgaris|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Acne Treatment
Acne treatment using the M22-IPL acne filter
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.
- lesion count of acne vulgaris will be reduced by at least 50% for >75% of the study population. [ Time Frame: week 6 (week 1 after the last treatment) ]The numbers of lesions are counted on each side of the face according to lesion type
- Investigator Global Assessment (IGA) Scale for Acne Vulgaris [ Time Frame: following the treatments: at Baseline ,5 weeks and at follow up 6 and 10 weeks. ]The investigator will be required to grade the acne severity using the IGA scale
- Subject Discomfort Evaluation [ Time Frame: Following the treatments: Baseline,2,3,4,5 weeks ]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.
- Long term side effect and adverse events [ Time Frame: throughout the duration of the study (Baseline,2,3,4,5 weeks) ]Any adverse events associated with various setting used during the treatment and follow-up period
- Subject Downtime Evaluation [ Time Frame: Following treatments baseline,2,3,4,5 weeks ]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
- Subject Satisfaction [ Time Frame: week 4 ,6 ,10 ]The assessment will be based on a 5-point Likert scale detailed in Table 5 where 0 represents dissatisfied and 4 represents very satisfied.
- The Cardiff Acne Disability Index [ Time Frame: Baseline ,4,6,10 weeks ]The Cardiff Acne Disability Index is a short 5 item questionnaire derived from the longer Acne Disability Index
- Subject personal experience [ Time Frame: week 10 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180282
|United States, Florida|
|Knight Dermatology Institute|
|Orlando, Florida, United States, 32801|
|Principal Investigator:||Dr. J. Matthew Knight, MD, FAAD||Knight Dermatology Institute|