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

NCT06655129 | Recruiting

• 1 other identifier: 13330805
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (3)

• Efficacity for Excessive Hairiness:

  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)

  up to 18 months

• Efficacity for Vascular lesions and Pigmented lesions

  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.

  up to 4 months

• Efficacity for Acne vulgaris

  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.

  up to 4 months

Secondary Outcomes (3)

• For all patients decrease of the IRBMS score

  4 to 18 months

• - For all patients decrease of the DLQI score

  4 to 18 months

• For only Acne patients, at least 20% reduction in the ECLA score

  4 to 18 months

Study Arms (1)

Intense Pulsed Light Treatment

EXPERIMENTAL

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

Device: intense pulsed light

Interventions

intense pulsed light DEVICE

intense pulsed light (IPL) using the Medical Device Anthelia

Intense Pulsed Light Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofeedback: lead

Study Sites (5)

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

MeSH Terms

Conditions

Hirsutism; Acne Vulgaris

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acneiform Eruptions; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Central Study Contacts

Laurent Zawadil

CONTACT

01 60 86 31 10; s.qualite@eurofeedback.com

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: April 23, 2024
• First Posted: October 23, 2024
• Study Start: January 20, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)