Impact of the M22-IPL Acne Filter on Acne Vulgaris

January 25, 2017 updated by: Lumenis Be Ltd.

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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Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32801
        • Knight Dermatology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acne Treatment
Acne treatment using the M22-IPL acne filter
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
week 6 (week 1 after the last treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
following the treatments: at Baseline ,5 weeks and at follow up 6 and 10 weeks.
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.
Following the treatments: Baseline,2,3,4,5 weeks
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
throughout the duration of the study (Baseline,2,3,4,5 weeks)
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
Following treatments baseline,2,3,4,5 weeks
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.
week 4 ,6 ,10
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
Baseline ,4,6,10 weeks
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
week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lumenis Be Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. J. Matthew Knight, MD, FAAD, Knight Dermatology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUM-ABU-M22-IPL-14-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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