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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
CH Auxerre
RECRUITING
Auxerre
HIACT Brest
RECRUITING
Brest
Centre TrialAzur
RECRUITING
Nice
CH Périgueux
NOT_YET_RECRUITING
Périgueux
CHU POitiers
RECRUITING
Poitiers
Contact Information
Primary
Laurent Zawadil
s.qualite@eurofeedback.com
01 60 86 31 10
Time Frame
Start Date: 2024-01-20
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 85
Treatments
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).
Sponsors
Leads: Eurofeedback

This content was sourced from clinicaltrials.gov