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

Post Market Clinical Study of an Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder

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

Study Overview

• Status: Recruiting
• Conditions: Acne Vulgaris; Pigmented Lesions; Vascular Lesion; Excessive Hairiness
• Intervention / Treatment: Device: intense pulsed light

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent Zawadil; Phone Number: 01 60 86 31 10; Email: s.qualite@eurofeedback.com

Study Locations

• France
  • Auxerre, France
    • Recruiting
    • CH Auxerre
  • Brest, France
    • Recruiting
    • HIACT Brest
  • Nice, France
    • Recruiting
    • Centre TrialAzur
  • Poitiers, France
    • Recruiting
    • CHU Poitiers
  • Périgueux, France
    • Not yet recruiting
    • CH Périgueux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intense Pulsed Light Treatment; Patients will be treated at different visits, and according to the IFU, with the Anthelia Medical Device (Intense Pulsed Light).	Device: intense pulsed light; intense pulsed light (IPL) using the Medical Device Anthelia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eurofeedback

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hair Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Virilism; Acne Vulgaris; Skin Diseases; Hirsutism; Hypertrichosis
• Other Study ID Numbers: 13330805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No