Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEurofeedback
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult men or women
Patient with unwanted hair on the body (legs, arms, bikini line, or axilla)
Patient over 18 years.
Patients with Fitzpatrick skin types from I to V.
Disqualifiers
Patients with history of malignant lesions or pre-malignant lesions, scarring, or infection in the area to be treated History of keloidal or hypertrophic scarring
Patients with a known photosensitivity
Pregnancy women
Patient with diabetes mellitus suntan in the area to be treated
Trial design
Design model
Single group
Treatments tested in this trial
intense pulsed light
Deviceintense pulsed light (IPL) using the Medical Device Anthelia
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: Intense Pulsed Light TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 monthsSecondary outcomes
1
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 months2
- 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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov