Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06655129

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

Led by Eurofeedback · Updated on 2024-10-23

85

Participants Needed

5

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult men or women
  • Patients with unwanted hair on the body (legs, arms, bikini line, or axilla)
  • Patients aged over 18 years
  • Patients with Fitzpatrick skin types I to V
  • Women must be post-menopausal, surgically sterilized, or using medically acceptable birth control during the study
  • Patients with vascular lesions such as varicosities and rosacea on face or limbs
  • Patients with pigmented lesions like solar lentigines larger than 3 mm on cheeks, back, hands, arms, or legs
  • Patients with facial acne vulgaris
  • Willingness to protect treated areas from sun exposure during the study and for 4 weeks after treatment
Not Eligible

You will not qualify if you...

  • History of malignant or pre-malignant lesions, scarring, or infection in treatment areas
  • History of keloidal or hypertrophic scarring
  • Known photosensitivity
  • Pregnant women
  • Diabetes mellitus
  • Suntan in the treatment area
  • Use of photosensitizing products within 7 days before treatment
  • Exposure to sun or UV rays within 4 weeks before treatment or 1 week after
  • Presence of uncovered tattoos, suspicious spots, or skin diseases in treatment areas
  • Use of medications causing anticoagulation or thromboembolic conditions
  • Presence of a pacemaker or internal defibrillator
  • Use of NSAIDs within 2 weeks before or after treatment
  • Epilepsy
  • For excessive hairiness: use of waxing or other photo epilation methods within 1 month before treatment
  • For acne: current use of oral antibiotics or oral acne therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

CH Auxerre

Auxerre, France

Actively Recruiting

2

HIACT Brest

Brest, France

Actively Recruiting

3

Centre TrialAzur

Nice, France

Actively Recruiting

4

CH Périgueux

Périgueux, France

Not Yet Recruiting

5

CHU POitiers

Poitiers, France

Actively Recruiting

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Research Team

L

Laurent Zawadil

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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