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

NCT ID: NCT06655129

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2025-12-01

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

Conditions

Excessive Hairiness; Vascular Lesion; Pigmented Lesions; Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intense Pulsed Light Treatment

Patients will be treated at different visits, and according to the IFU, with the Anthelia Medical Device (Intense Pulsed Light).

Group Type: EXPERIMENTAL

intense pulsed light

Intervention Type: DEVICE

intense pulsed light (IPL) using the Medical Device Anthelia

Interventions

intense pulsed light

intense pulsed light (IPL) using the Medical Device Anthelia

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eurofeedback

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH Auxerre

Auxerre, , France

Site Status: RECRUITING

HIACT Brest

Brest, , France

Site Status: RECRUITING

Centre TrialAzur

Nice, , France

Site Status: RECRUITING

CH Périgueux

Périgueux, , France

Site Status: NOT_YET_RECRUITING

CHU POitiers

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurent Zawadil

Role: CONTACT

s.qualite@eurofeedback.com

01 60 86 31 10

Other Identifiers

13330805

Identifier Type: -

Identifier Source: org_study_id