What is the Anthelia IPL device studying for skin disorders?

The Anthelia IPL device is being studied to evaluate its effects on excessive hairiness, vascular lesions, pigmented lesions, and acne vulgaris. Researchers aim to understand how the device works in treating these skin conditions and improving patients' skin appearance. The study is sponsored by Eurofeedback and monitors multiple outcomes over several months.

Who may be eligible for this skin disorder clinical trial?

Adults 18 years or older with specific skin conditions such as unwanted hair, vascular lesions, pigmented spots, or acne may be eligible. Women must be post-menopausal or using acceptable birth control methods. People with photosensitivity, pregnancy, certain skin diseases, or recent use of specific medications may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this skin disorder clinical trial?

Study-related care, including the use of the Anthelia IPL device and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants can plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

Healthy Volunteers

ID06655129

Clinical Study of the Anthelia Intense Pulsed Light Device for Treating Skin Conditions Including Excessive Hairiness, Vascular and Pigmented Lesions, and Acne Vulgaris

Led by Eurofeedback · Updated on 2024-10-23

Participants Needed

Research Sites

48 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the Anthelia Intense Pulsed Light IPL medical device for treating various skin conditions including excessive hairiness, vascular lesions, pigmented lesions, and acne vulgaris. The study is a post-market clinical trial conducted to assess the devices effectiveness and safety in these skin disorders. The IPL device has been FDA-cleared since 1995 and is noted for its cost-effectiveness and versatility compared to single-spectrum lasers. Participants will receive treatment with the Anthelia IPL device during multiple visits, following the devices instructions for use. The treatments target unwanted hair, varicosities, rosacea, solar lentigines, and facial acne, with specific inclusion criteria for skin types and condition characteristics. The study includes follow-up periods ranging up to 18 months to evaluate treatment effects. During the study, participants will undergo assessments to measure effectiveness using scores such as IRBMS, DLQI, and ECLA for acne patients. Safety and treatment response will be monitored over periods from 4 to 18 months depending on the condition treated. Participants will be evaluated regularly to track improvements in hairiness, vascular and pigmented lesions, and acne, ensuring comprehensive monitoring throughout the trial.

CONDITIONS

Brief 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

You may qualify if you...

Adult men or women
Patients over 18 years old
Patients with Fitzpatrick skin types I to V for excessive hairiness
Women must be post-menopausal, surgically sterilized, or using medically acceptable birth control during the study
Patients with unwanted hair on legs, arms, bikini line, or axilla
Patients with Fitzpatrick skin types I to IV for vascular lesions
Patients with varicosities and rosacea on face or limbs
Patients with Fitzpatrick skin type I to IV for pigmented lesions
Patients with solar lentigines larger than 3 mm on cheeks, back, hands, arms, or legs
Patients with Fitzpatrick skin types I to IV for acne
Patients with facial acne vulgaris
Willingness to protect treated area from sun during and 4 weeks after treatment

You will not qualify if you...

History of malignant or premalignant lesions, scarring, or infection in treatment area
History of keloidal or hypertrophic scarring
Known photosensitivity
Pregnant women
Diabetes mellitus
Suntan in treatment area
Use of photosensitizing products within 7 days before treatment
Exposure to sun or UV rays within 4 weeks before and 1 week after treatment
Presence of tattoos, suspicious spots, or skin diseases (including psoriasis, herpes, tumors, melanomas) in treatment area
Use of anticoagulant medication or thromboembolic conditions
Presence of pacemaker or internal defibrillator
Use of NSAIDs two weeks before or after treatment
Epilepsy
Use of waxing or other photo epilation methods within 1 month prior to treatment (for excessive hairiness)
Current oral antibiotic or oral therapy for acne (for acne patients)

Research Team

Laurent Zawadil

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Clinical Study of the Anthelia Intense Pulsed Light Device for Treating Skin Conditions Including Excessive Hairiness, Vascular and Pigmented Lesions, and Acne Vulgaris

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria