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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intense Pulsed Light Treatment | Experimental | Patients will be treated at different visits, and according to the IFU, with the Anthelia Medical Device (Intense Pulsed Light). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intense pulsed light | Device | intense pulsed light (IPL) using the Medical Device Anthelia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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. | up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| For all patients decrease of the IRBMS score | IRBMS (Rosenberg Self-Esteem Scale), minimum score is 10, maximum score is 40 | 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 |
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Inclusion Criteria:
Vascular lesions:
Pigmented lesions:
Acne:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent Zawadil | Contact | 01 60 86 31 10 | s.qualite@eurofeedback.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Auxerre | Recruiting | Auxerre | France | |||
| HIACT Brest |
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| ID | Term |
|---|---|
| D006628 | Hirsutism |
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014770 | Virilism |
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| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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| 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 | 4 to 18 months |
| Recruiting |
| Brest |
| France |
| Centre TrialAzur | Recruiting | Nice | France |
| CH Périgueux | Not yet recruiting | Périgueux | France |
| CHU POitiers | Recruiting | Poitiers | France |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |