Actively Recruiting
Post Market Clinical Study of the Anthelia Intense Pulsed Light (IPL) Medical Device for Treatment of Skin Disorders
Led by Eurofeedback · Updated on 2024-10-23
85
Participants Needed
5
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Anthelia Intense Pulsed Light (IPL) medical device for treating various skin conditions including excessive hairiness, vascular lesions, pigmented lesions, and acne vulgaris. The study is a post-market clinical trial conducted to assess the device's effectiveness and safety in these skin disorders. The IPL device has been FDA-cleared since 1995 and is noted for its cost-effectiveness and versatility compared to single-spectrum lasers. Participants will receive treatment with the Anthelia IPL device during multiple visits, following the device's instructions for use. The treatments target unwanted hair, varicosities, rosacea, solar lentigines, and facial acne, with specific inclusion criteria for skin types and condition characteristics. The study includes follow-up periods ranging up to 18 months to evaluate treatment effects. During the study, participants will undergo assessments to measure effectiveness using scores such as IRBMS, DLQI, and ECLA for acne patients. Safety and treatment response will be monitored over periods from 4 to 18 months depending on the condition treated. Participants will be evaluated regularly to track improvements in hairiness, vascular and pigmented lesions, and acne, ensuring comprehensive monitoring throughout the trial.
CONDITIONS
Brief Title
Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men or women
- Patients over 18 years old
- Patients with Fitzpatrick skin types I to V for excessive hairiness
- Women must be post-menopausal, surgically sterilized, or using medically acceptable birth control during the study
- Patients with unwanted hair on legs, arms, bikini line, or axilla
- Patients with Fitzpatrick skin types I to IV for vascular lesions
- Patients with varicosities and rosacea on face or limbs
- Patients with Fitzpatrick skin type I to IV for pigmented lesions
- Patients with solar lentigines larger than 3 mm on cheeks, back, hands, arms, or legs
- Patients with Fitzpatrick skin types I to IV for acne
- Patients with facial acne vulgaris
- Willingness to protect treated area from sun during and 4 weeks after treatment
You will not qualify if you...
- History of malignant or premalignant lesions, scarring, or infection in treatment area
- History of keloidal or hypertrophic scarring
- Known photosensitivity
- Pregnant women
- Diabetes mellitus
- Suntan in treatment area
- Use of photosensitizing products within 7 days before treatment
- Exposure to sun or UV rays within 4 weeks before and 1 week after treatment
- Presence of tattoos, suspicious spots, or skin diseases (including psoriasis, herpes, tumors, melanomas) in treatment area
- Use of anticoagulant medication or thromboembolic conditions
- Presence of pacemaker or internal defibrillator
- Use of NSAIDs two weeks before or after treatment
- Epilepsy
- Use of waxing or other photo epilation methods within 1 month prior to treatment (for excessive hairiness)
- Current oral antibiotic or oral therapy for acne (for acne patients)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants receive treatment with the Anthelia Intense Pulsed Light (IPL) Medical Device at different visits according to the device instructions.
Multiple treatment visits depending on individual needs
Duration - Up to 18 months
Participants are monitored for efficacy and safety outcomes related to excessive hairiness, vascular and pigmented lesions, and acne vulgaris.
Periodic follow-up visits as scheduled by the study team
Trial Site Locations
Total: 5 locations
1
CH Auxerre
Auxerre, France
Actively Recruiting
2
HIACT Brest
Brest, France
Actively Recruiting
3
Centre TrialAzur
Nice, France
Actively Recruiting
4
CH Périgueux
Périgueux, France
Not Yet Recruiting
5
CHU POitiers
Poitiers, France
Actively Recruiting
Research Team
L
Laurent Zawadil
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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