Intense Pulsed Light
Deviceintense pulsed light (IPL) using the Medical Device Anthelia
NCT Number: NCT06655129
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
CH Auxerre, Auxerre, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Vascular lesions:
Pigmented lesions:
Acne:
Exclusion criteria
intense pulsed light (IPL) using the Medical Device Anthelia
Time frame: up to 18 months
Excessive Hairiness by hair counting a 4cm2 surface (To demonstrate a hair reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as six sessions spaced by 12 weeks)
Time frame: up to 4 months
Vascular lesions: To demonstrate a reduction of 70% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks.
To demonstrate a clinical improvement of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks.
Pigmented Lesions: To demonstrate a reduction of 60% between the average score of the treated aera before and after a cycle of treatment defined as three sessions spaced by 10 weeks.
Time frame: up to 4 months
measuring the diameter of each pimple in a treated area (before and after), To demonstrate a lesion reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 2 weeks.
Time frame: 4 to 18 months
IRBMS (Rosenberg Self-Esteem Scale), minimum score is 10, maximum score is 40
Time frame: 4 to 18 months
DLQI (Dermatology Life Quality Index), minimum score is 0, maximum score is 30
Time frame: 4 to 18 months
ECLA ("Echelle de Cotation des Lésions d'Acné" or Acne Lesion Score Scale), minimum score is 0, maximum score is 36
Contact information is provided by the study sponsor or research team.
Eurofeedback
Industry
Post Market Clinical Study of an Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
Acronym: Anthelia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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