AcneNCT02180282
Impact of the M22-IPL Acne Filter on Acne Vulgaris
A study testing M22-IPL in people with Acne, run by Lumenis Be Ltd. at 1 site in United States.
Trial 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. . Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- M22-IPL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Able to read, understand and provide written Informed Consent;
- Healthy male or female, 15-45 years of age;
- Fitzpatrick skin type I-V;
- Have at least 15 inflammatory lesions (papules and pustules) in the face.
- Having clinical diagnosis of mild to moderate inflammatory acne on face with Investigator Global Acne scale = 2 and 3;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- 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.
Who cannot join
- Skin type VI;
- Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding;
- Heavy smoker (>1 pack of cigarettes a day);
- Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study;
- Photosensitivity or any sensitivity to the sun that causes a rash or allergic reaction;
- Use of photosensitive medication for which light exposure is contraindicated;
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- Treatment with topical retinoid therapy or antibiotics for the treatment of acne within 2 weeks of study enrollment or during the study.
- Treatment with oral retinoid medications (Accutane® or Soriatane®) within 6 months of the study enrollment or during the study.
- Treatment with any topical or systemic anti acne therapy for at least 2 weeks prior to starting the study treatment or during the study.
- Any history of gold therapy;
- 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;
- 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;
- Any other surgery in treated area within 9 months of initial treatment or during the course of the study;
- 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;
- History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area;
- Showing symptoms of hormonal disorders, as per the Investigator's discretion (such as Melasma, Chloasma);
- Concurrent inflammatory skin conditions, Open laceration or abrasion of any sort on area to be treated during the course of treatment;
- 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;
- 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);
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
- 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;
- Mentally incompetent or evidence of active substance or alcohol abuse;
- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Knight Dermatology Institute
Orlando, Florida, 32801
About this study
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.
.
- Conditions
- Acne
- Being tested
- M22-IPL
- Keywords
- Acne Treatment
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M22-IPLDevice
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 group | Role | What they receive |
|---|---|---|
| Acne Treatment | Experimental | Acne treatment using the M22-IPL acne filter Receives: Device: M22-IPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 6 (week 1 after the last treatment)
Secondary outcomes (7)
Investigator Global Assessment (IGA) Scale for Acne Vulgaris
The investigator will be required to grade the acne severity using the IGA scale
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Low recruiting rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. J. Matthew Knight, MD, FAAD, Principal investigator, Knight Dermatology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180282
- Sponsor's protocol ID
- LUM-ABU-M22-IPL-14-01
- Status last verified
- Jan 2017
- First submitted
- 1 Jul 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the M22-IPL Acne Filter on Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02180282
- Acronym / sponsor ID
- LUM-ABU-M22-IPL-14-01
- Conditions
- Acne
- Keywords
- Acne Treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruiting rate
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acne Treatment | Experimental | Device: M22-IPLAcne treatment using the M22-IPL acne filter |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Able to read, understand and provide written Informed Consent;
- Healthy male or female, 15-45 years of age;
- Fitzpatrick skin type I-V;
- Have at least 15 inflammatory lesions (papules and pustules) in the face.
- Having clinical diagnosis of mild to moderate inflammatory acne on face with Investigator Global Acne scale = 2 and 3;
Key exclusion criteria (24 listed)
- Skin type VI;
- Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding;
- Heavy smoker (>1 pack of cigarettes a day);
- Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study;
- Photosensitivity or any sensitivity to the sun that causes a rash or allergic reaction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M22-IPLThe 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. | Device | Acne Treatment |
Primary outcome
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
7 secondary outcomes
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.
Subject Discomfort Evaluation
Time frame: 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)
Subject Downtime Evaluation
Time frame: Following treatments baseline,2,3,4,5 weeks
Subject Satisfaction
Time frame: week 4 ,6 ,10
The Cardiff Acne Disability Index
Time frame: Baseline ,4,6,10 weeks
Subject personal experience
Time frame: week 10
Results and safety
The study was stopped early (reason given: Low recruiting rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. J. Matthew Knight, MD, FAAD principal investigator
Knight Dermatology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M22-IPL in people with Acne, run by Lumenis Be Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruiting rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.