THE USE OF MELANOCYTE/KERATINOCYTE CO-SUSPENSION FOR THE RE-PIGMENTATION OF AMELANOTIC PATCHES IN VITILIGO
Not Applicable
Completed
- Conditions
- VitiligoSkin - Dermatological conditions
- Registration Number
- ACTRN12607000635460
- Lead Sponsor
- Royal Adelaide Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Patients must have established vitiligo of any duration (an idea of the efficacy of the treatment in early, active vitiligo must be gained).
Patients must be > 18 years old
Patients must be able and willing to provide consent to all aspects of the study following verbal and written explanation of the study by the investigating clinician.
Patients must have a leukodermic patch for study, which is outside cosmetically sensitive areas such as the face ie low back, medial thigh, medial arm etc.
Patients must have no documented previous reaction to local anaesthetic agents.
Exclusion Criteria
Any contraindication to surgery/anaesthesia
Any failure of consent process
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Repigmentation-<br>The Visual Pigmentation Scoring Scale (VPSS) will be used to assess re-pigmentation See below for description of scoring scale.<br><br>KP-No pigmentation (previously pigmented area)<br>0-No pigmentation (vitiligo area)<br>1-Minimal pigmentation<br>2-Slight pigmentation<br>3-Normal pigmentation<br>4-Slight hyperpigmentation<br>5-Marked hyperpigmentation<br>KP=Koebner?s Phenomenon. <br><br>Measurement of colour change will also be performed using a miniature fibre-optic spectrometer (StellarNet Inc., Oldsmar, 34677, USA), and supporting digital photographs will be taken at each time point using a Sony 5.2 megapixel camera with macro lens.[3,6,9,12,24,36,52 weeks]
- Secondary Outcome Measures
Name Time Method RATE OF REEPITHELIALISATION by direct clinical visualisation supprted by colour digital photography.[Daily (from day 3) until epithelialised]