Using Intense Pulsed Light to Treat Various Skin Disorders
Post Market Clinical Study of an Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
This study is testing a new light treatment to see if it can help adults with different skin problems like acne, unwanted hair, and discoloration feel better about their skin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eurofeedback Industry-sponsored |
| Locations | 5 sites (Auxerre and 4 other locations) |
| Trial ID | NCT06655129 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the ANTHÉLIA medical device, which utilizes intense pulsed light (IPL) technology to treat several skin disorders, including excessive hairiness, vascular lesions, pigmented lesions, and acne vulgaris. The study aims to assess the safety and efficacy of this versatile treatment option for adult patients with specific skin types and conditions. Participants will receive IPL treatments tailored to their individual skin concerns, with the goal of improving their skin appearance and health.
Who should consider this trial
Good fit: Ideal candidates include adult men and women over 18 years with specific skin conditions such as excessive hairiness, vascular lesions, pigmented lesions, or acne vulgaris, and who fit within the specified Fitzpatrick skin types.
Not a fit: Patients with skin types outside the specified Fitzpatrick classifications or those with conditions not addressed by the IPL treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide patients with a non-invasive option to effectively manage and improve various skin disorders.
How similar studies have performed: Previous studies have shown success with IPL technology in treating similar skin conditions, indicating a promising approach for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult men or women * Excessive Hairiness: * Patient with unwanted hair on the body (legs, arms, bikini line, or axilla) * Patient over 18 years. * Patients with Fitzpatrick skin types from I to V. * Women were required to be post-menopausal, surgically sterilized, or under a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, or barrier methods with spermicide or abstinence) during the study time period. Vascular lesions: * Patients over 18 years. * Patients with Fitzpatrick skin types from I to IV. * Patients with varicosities and Rosacea on the face or upper and lower limbs. Pigmented lesions: * Patients over 18 years. * Patients with solar lentigines on their cheeks, back, hands, arm and leg (\> 3 mm). * Patient with Fitzpatrick skin type from I to IV. Acne: * Patients over 18 years * Patients with Fitzpatrick skin types from I to IV. * Patients with facial acne vulgaris on face. * Willing to sun protect treated area for the duration of enrollment in the study and 4 weeks after treatment. Exclusion Criteria: * Patients with history of malignant lesions or pre-malignant lesions, scarring, or infection in the area to be treated History of keloidal or hypertrophic scarring * Patients with a known photosensitivity * Pregnancy women * Patient with diabetes mellitus suntan in the area to be treated * Use of photo-sensitizing products for 7 days before treatment (selftanning lotions, activators, self-tanning shower gel, etc.) * Exposure to the sun or UV rays at least 4 weeks before the treatment and 1 week afterwards * Zones with uncovered tattoos, suspect spots or skin diseases (including spots, inflammation, beauty spots, tumors or melanomas, psoriasis, herpes...) * Use of medication that induces anticoagulative medication or thromboembolic condition * Patients with pacemaker or internal defibrillator * Patients that used of NSAIDS two weeks prior to or 2 weeks following the treatment * Epileptic patients * Additional criteria for excessive hair: Patients that use waxing or other methods of photo epilation within 1 month prior to treatment. * Additional criteria for acne: Patients currently under oral antibiotic or oral therapy for acne.
Where this trial is running
Auxerre and 4 other locations
- CH Auxerre — Auxerre, France (Recruiting)
- HIACT Brest — Brest, France (Recruiting)
- Centre TrialAzur — Nice, France (Recruiting)
- CH Périgueux — Périgueux, France (Not_yet_recruiting)
- CHU POitiers — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Laurent Zawadil
- Email: s.qualite@eurofeedback.com
- Phone: 01 60 86 31 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.