An interventional study of intense pulsed light in Excessive Hairiness, Vascular Lesion and Pigmented Lesions, sponsored by Eurofeedback. Recruiting at 5 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Eurofeedback · Not applicable, Interventional, and Treatment
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:
41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.
This study's planned enrollment of 85 is above the median of 43 across 26 interventional studies indexed under Hirsutism.
Browse Hirsutism studies →This is the only study on the registry with Eurofeedback as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Vascular lesions:
Pigmented lesions:
Acne:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be treated at different visits, and according to the IFU, with the Anthelia Medical Device (Intense Pulsed Light).
Device: intense pulsed light
intense pulsed light (IPL) using the Medical Device Anthelia
Efficacity for Excessive Hairiness:
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 18 months
Efficacity for Vascular lesions and Pigmented lesions
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
Efficacity for Acne vulgaris
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: up to 4 months
For all patients decrease of the IRBMS score
IRBMS (Rosenberg Self-Esteem Scale), minimum score is 10, maximum score is 40
Time frame: 4 to 18 months
- For all patients decrease of the DLQI score
DLQI (Dermatology Life Quality Index), minimum score is 0, maximum score is 30
Time frame: 4 to 18 months
For only Acne patients, at least 20% reduction in the ECLA score
ECLA ("Echelle de Cotation des Lésions d'Acné" or Acne Lesion Score Scale), minimum score is 0, maximum score is 36
Time frame: 4 to 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2024, 11 months after the start.
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