Status:

RECRUITING

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

Lead Sponsor:

Eurofeedback

Conditions:

Excessive Hairiness

Vascular Lesion

Eligibility:

All Genders

18+ years

Phase:

NA

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 con...

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.

Key Trial Info

Start Date :

January 20 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

85 Patients enrolled

Trial Details

Trial ID

NCT06655129

Start Date

January 20 2024

End Date

December 1 2025

Last Update

October 23 2024

Active Locations (5)

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Page 1 of 2 (5 locations)

1

CH Auxerre

Auxerre, France

2

HIACT Brest

Brest, France

3

Centre TrialAzur

Nice, France

4

CH Périgueux

Périgueux, France

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