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

Last updated: October 21, 2024
Sponsor: Eurofeedback
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scalp Disorders

Rash

Acne

Treatment

intense pulsed light

Clinical Study ID

NCT06655129
13330805
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 amedically acceptable form of birth control (i.e., oral contraceptives, IUD,contraceptive implant, or barrier methods with spermicide or abstinence) during thestudy 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

Exclusion Criteria:

  • Patients with history of malignant lesions or pre-malignant lesions, scarring, orinfection 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 weekafterwards

  • 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 thromboemboliccondition

  • 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 ofphoto epilation within 1 month prior to treatment.

  • Additional criteria for acne: Patients currently under oral antibiotic or oraltherapy for acne.

Study Design

Total Participants: 85
Treatment Group(s): 1
Primary Treatment: intense pulsed light
Phase:
Study Start date:
January 20, 2024
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • CH Auxerre

    Auxerre,
    France

    Active - Recruiting

  • HIACT Brest

    Brest,
    France

    Active - Recruiting

  • Centre TrialAzur

    Nice,
    France

    Active - Recruiting

  • CHU POitiers

    Poitiers,
    France

    Active - Recruiting

  • CH Périgueux

    Périgueux,
    France

    Site Not Available

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