Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
The treatment of vitiligo remains disappointing especially in some localization such as bony prominences and extremities. The association of UVB and topical steroids has been proven to be synergistic but the results are still insufficient in those difficult to treat areas. Promising results have been shown with the combination of laser assisted dermabrasion, topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin followed by topical steroids should potentialized the effect of UVB and be superior to topical steroids and UVB without dermabrasion.
The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion combined to topical steroids and UVB phototherapy in difficult to treat areas.
Patients with symmetrical non segmental vitiligo will be included in this prospective randomized monocentrer study. The investigators calculated the number of patients needed at 25. The side that will receive the dermabrasion will be centrally randomized and the opposite side will serve as control. Then on both side class 3 topical steroids will be applied daily 3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks.
The evaluation will be performed by two independent physician blinded to the treatment of standardized photos before and 1 month after the end of the treatment. The criteria of success will be at least 75% of repigmentation.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, Frankrike, 06001
- CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age between 18 at 85
- Not segmental Vitiligo of clinical diagnosis located on bony projections or of ends
- Two symmetrical plates of vitiligo of more than 4 cm ²
Exclusion Criteria:
- Pregnant women or breastfeeding.
- Vitiligo lesions on face and neck
- Personal history of skin cancer
- Photosensitize drugs
- Personal history of photodermatosis
- Personal history of keloids
- Concomitant treatment that could have an action on vitiligo (such as tacrolimus or pimecrolimus).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Group Laser = Arm As A
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
|
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
|
|
Placebo komparator: Bras B : the control group
patient to accept habitual treatment of corticoid
|
patient to accept habitual treatment of corticoid Opposite side lesions that will receive only the treatment by topical steroids
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy
Tidsramme: 4 months
|
Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy
|
4 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: PASSERON Ph Thierry, Md, CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09-PP-08
- 2010-A00021-38 (Annet stipend/finansieringsnummer: AFSSAPS)
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