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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
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.

Tracking Information
First Submitted Date  ICMJE July 1, 2014
First Posted Date  ICMJE July 2, 2014
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE July 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02180282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of the M22-IPL Acne Filter on Acne Vulgaris
Official Title  ICMJE Impact of the M22-IPL Acne Filter on Acne Vulgaris
Brief Summary

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.

.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE Device: M22-IPL

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.

Study Arms  ICMJE Experimental: Acne Treatment
Acne treatment using the M22-IPL acne filter
Intervention: Device: M22-IPL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 17, 2016)
13
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Able to read, understand and provide written Informed Consent;
  2. Healthy male or female, 15-45 years of age;
  3. Fitzpatrick skin type I-V;
  4. Have at least 15 inflammatory lesions (papules and pustules) in the face.
  5. Having clinical diagnosis of mild to moderate inflammatory acne on face with Investigator Global Acne scale = 2 and 3;
  6. Able and willing to comply with the treatment/follow-up schedule and requirements;
  7. Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, Nova ring, and partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.

Exclusion Criteria:

  1. Skin type VI;
  2. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding;
  3. Heavy smoker (>1 pack of cigarettes a day);
  4. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study;
  5. Photosensitivity or any sensitivity to the sun that causes a rash or allergic reaction;
  6. Use of photosensitive medication for which light exposure is contraindicated;
  7. Treatment with topical retinoid therapy or antibiotics for the treatment of acne within 2 weeks of study enrollment or during the study.
  8. Treatment with oral retinoid medications (Accutane® or Soriatane®) within 6 months of the study enrollment or during the study.
  9. Treatment with any topical or systemic anti acne therapy for at least 2 weeks prior to starting the study treatment or during the study.
  10. Any history of gold therapy;
  11. Prior use of collagen, fat injections or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 12 months of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants;
  12. Prior ablative resurfacing procedure or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study;
  13. Any other surgery in treated area within 9 months of initial treatment or during the course of the study;
  14. Participation in a study of another investigational device or drug involving the same anatomical site within 3 month prior to enrollment or during this evaluation, or if not involving the same anatomical site, as per the Investigator's discretion;
  15. History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area;
  16. Showing symptoms of hormonal disorders, as per the Investigator's discretion (such as Melasma, Chloasma);
  17. Concurrent inflammatory skin conditions, Open laceration or abrasion of any sort on area to be treated during the course of treatment;
  18. Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study enrollment;
  19. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion);
  20. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
  21. Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer on the face;
  22. Mentally incompetent or evidence of active substance or alcohol abuse;
  23. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study;
  24. For subjects undergoing test spots: considerable undesired response consisting of skin hypopigmentation (long term whitening), a scar or pre scar formation or any response deemed by the Investigator as grounds for exclusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02180282
Other Study ID Numbers  ICMJE LUM-ABU-M22-IPL-14-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lumenis Ltd.
Study Sponsor  ICMJE Lumenis Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. J. Matthew Knight, MD, FAAD Knight Dermatology Institute
PRS Account Lumenis Ltd.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP