Impact of the M22-IPL Acne Filter on Acne Vulgaris

NCT02180282 | Terminated

• 1 other identifier: LUM-ABU-M22-IPL-14-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. .

Conditions

Acne

Keywords

Acne Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  week 6 (week 1 after the last treatment)

Secondary Outcomes (7)

• Investigator Global Assessment (IGA) Scale for Acne Vulgaris

  following the treatments: at Baseline ,5 weeks and at follow up 6 and 10 weeks.

• Subject Discomfort Evaluation

  Following the treatments: Baseline,2,3,4,5 weeks

• Long term side effect and adverse events

  throughout the duration of the study (Baseline,2,3,4,5 weeks)

• Subject Downtime Evaluation

  Following treatments baseline,2,3,4,5 weeks

• Subject Satisfaction

  week 4 ,6 ,10

Study Arms (1)

Acne Treatment

EXPERIMENTAL

Acne treatment using the M22-IPL acne filter

Device: M22-IPL

Interventions

M22-IPL DEVICE

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.

Acne Treatment

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (1)

Knight Dermatology Institute

Orlando, Florida, 32801, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Dr. J. Matthew Knight, MD, FAAD

  Knight Dermatology Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

US (1)