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A clinical trial to study the effect of intra operative use of platelet rich plasma on the outcome of melanocyte transplant surgery

To study the efficacy and safety of intra-operative use of Platelet rich plasma(PRP) in autologous non cultured epidermal cell suspension (NCECS) grafting when compared to autologous non cultured epidermal cell suspension alone in surgical management of stable vitiligo. - NCS-PRP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012591
Enrollment
30
Registered
2018-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Stable Vitiligo

Interventions

Intervention1: Non cultured Melanocyte transplant: Patients shall serve as their controls to optimize matching cases with controls. In that, two equal and where applicable, symmetric areas of stable v

Sponsors

Intitutional research committee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with stable Vitilgo with no increase in size of lesion for past 06 months

Exclusion criteria

Exclusion criteria: 1) Unstable vitiligo (New lesion or extension of pre-existing lesion) 2) Vitiligo stabilized on systemic medical therapy 3) Evidence or history of keloid/hypertrophic scars. 4) Patients with chronic auto immune and infectious diseases e.g. DM, Thyroid disease, HTN, Hep B,C,HIV etc. 5) Patients with bleeding disorders or on medications affecting platelet function e.g. Ecosprin.

Design outcomes

Primary

MeasureTime frame
The primary measure of efficacy of treatment is the percentage of repigmentation 06(Six) months after surgery which will be assessed by two independent investigators and the lesser value will be used for assessment of results. Pigmentation will be graded as excellent(90%), very good (76â??90%), goo (51â??75%), fair (26â??50%), and poor (25%).Timepoint: One, three and six months

Secondary

MeasureTime frame
Improvement in Dermatology Life Quality Index (DLQI) score (assessed before and 6 months after surgery) and patient satisfaction assessed by asking patients to complete a patient satisfaction questionnaire. Additionally, adverse events will be noted as a safety outcome measure. Timepoint: Before and 6 months after surgery

Countries

India

Contacts

Public ContactLt Col Vikas Pathania

Command Hospital Pune

vikascongo@yahoo.co.in9599847519

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026