Actively Recruiting
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
Eligibility Criteria
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
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
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
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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