Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder

Not Applicable

Recruiting

• Conditions: Excessive Hairiness; Vascular Lesion; Pigmented Lesions; Acne Vulgaris

• Registration Number: NCT06655129
• Lead Sponsor: Eurofeedback

Brief Summary

The first IPL device obtained United States Food and Drug Administration (FDA) clearance in 1995 for treatment of lower extremity telangiectasias. Since then, its favorable cost and versatility in contrast to many singlespectrum lasers, has led to its rapid proliferation and use in a number of different clinical settings. As described in the literature, ANTHÉLIA medical device is intended to treat skin disorders:

* Excessive Hairiness (Hirsutism, Hypertrichosis...)

* Vascular lesions (Rosacea....)

* Pigmented lesions (Lentigo et melasma)

* Acne vulgaris

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-20
• Study First Submitted: 2024-04-23
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacity for Excessive Hairiness:	up to 18 months	Excessive Hairiness by hair counting a 4cm2 surface (To demonstrate a hair reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as six sessions spaced by 12 weeks)
Efficacity for Vascular lesions and Pigmented lesions	up to 4 months	Vascular lesions: To demonstrate a reduction of 70% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks.; To demonstrate a clinical improvement of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks.; Pigmented Lesions: To demonstrate a reduction of 60% between the average score of the treated aera before and after a cycle of treatment defined as three sessions spaced by 10 weeks.
Efficacity for Acne vulgaris	up to 4 months	measuring the diameter of each pimple in a treated area (before and after), To demonstrate a lesion reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 2 weeks.

Secondary Outcome Measures

Name	Time	Method
For all patients decrease of the IRBMS score	4 to 18 months	IRBMS (Rosenberg Self-Esteem Scale), minimum score is 10, maximum score is 40
- For all patients decrease of the DLQI score	4 to 18 months	DLQI (Dermatology Life Quality Index), minimum score is 0, maximum score is 30
For only Acne patients, at least 20% reduction in the ECLA score	4 to 18 months	ECLA ("Echelle de Cotation des Lésions d'Acné" or Acne Lesion Score Scale), minimum score is 0, maximum score is 36

Trial Locations

Locations (5)

CH Auxerre; 🇫🇷 Auxerre, France

HIACT Brest; 🇫🇷 Brest, France

Centre TrialAzur; 🇫🇷 Nice, France

CHU POitiers; 🇫🇷 Poitiers, France

CH Périgueux; 🇫🇷 Périgueux, France