Clinical trial NCT06655129: Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
Official title: Post Market Clinical Study of an Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Excessive Hairiness
Vascular Lesion
Pigmented Lesions
Acne Vulgaris
Lead sponsor: Eurofeedback
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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.

Primary outcomes:
measure: Efficacity for Excessive Hairiness:
timeFrame: up to 18 months
measure: Efficacity for Vascular lesions and Pigmented lesions
timeFrame: up to 4 months
measure: Efficacity for Acne vulgaris
timeFrame: up to 4 months
Secondary outcomes:
measure: For all patients decrease of the IRBMS score
timeFrame: 4 to 18 months
measure: - For all patients decrease of the DLQI score
timeFrame: 4 to 18 months
measure: For only Acne patients, at least 20% reduction in the ECLA score
timeFrame: 4 to 18 months
Other outcomes:
Locations:
city: Auxerre
country: France
facility: CH Auxerre
city: Brest
country: France
facility: HIACT Brest
city: Nice
country: France
facility: Centre TrialAzur
city: Poitiers
country: France
facility: CHU POitiers
city: Périgueux
country: France
facility: CH Périgueux
Study officials:
References: