Skip to content

Autologous punch grafting in vitiligo patients: the effect of punchdepth and punchsize

Autologous punch grafting in vitiligo patients: the effect of punchdepth and punchsize - Punch grafting techniques in vitiligo

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35887
Enrollment
35
Registered
2011-07-21
Start date
2011-06-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

leucoderma

Interventions

Both the donorsite and recipient site first will be treated with a local anaesthetic of Lidocain 2% with adrenaline. The punchgrafts will be taken from the depigmented acceptor region to prepare thi
320*400 nm) facial tanner (HB 171, Philips BV Eindhoven, the Netherlands) at a power density of 8 mW/cm2. The exposure-time increases from 4 to 8 to 12 min in the first three sessions. From the four

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Patients with non-segmental and segmental vitiligo under medical treatment at the Netherlands Institute for Pigment Disorders -Age between 18 and 60 years -Patient is willing and able to give written informed consent -Vitiligo stable since 12 months without systemic therapy or 6 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions. -Vitiligo lesions on the extremities or trunk larger than 5x5cm

Exclusion criteria

Exclusion criteria: -UV therapy or systemic immunosuppressive treatment during the last 12 months -Local treatment of vitiligo during the last 6 months -Vitiligo lesions with folliculair or non-folliculair repigmentations -Skin type 1 -Hypertrophic scars -Keloid -Cardial insufficiency -Patients with a history of hypersensitivity to (UVB) light and allergy to local anesthesia. -Patients who are pregnant or breast-feeding -Patients not competent to understand what the procedures involved -Patients with a personal history of melanoma or non-melanoma skin cancer -Patients with a first degree relative with melanoma skin cancer -Patients with atypical nevi.

Design outcomes

Primary

MeasureTime frame
Objective assessment of the repigmentation 3 and 6 months after punch grafting. Assessment will be done using a ruler on a dermatoscope to measure the diameter of the growth of the punchgrafts. The surface of repigmentation will be calculated. Visual assessment of side effects (hyperpigmentation, hypopigmentation, scar, cobble stone effect on a scale from 0-3) by a blinded investigator. Number of grafts with repigmentation

Secondary

MeasureTime frame
Time to heal after grafting General outcome assessed by patient. How do you judge the general outcome of the procedure? (Poor, Moderate, Good, Excellent) (at 3 and 6 months) Other assessments: o Photodocumentation: A Canon G6 is used under standardised circumstances (camera setting, distance and flash with polarisation) for photodocumentation. Photographs will be taken before and 3 months after the treatment. o Classification of skin photo type (intake). Skin Photo type Reaction to sun exposure Skin Color I Burn and no tan Pale white II Burn and minimal tan Pale white III Burn and tan well White IV Tan, no burn Light brown V Tan, no burn Brown VI Tan, no burn Dark brown o Duration of the disease (intake) i. 0-6 months ii. 6-12 months iii. 1-5 years iv. 5-10 years v. > 10 years Disease activity (intake): Disease activity VIDA score Active in the past 6 weeks +4 Active in the past 3 months +3 Active in the past 6 months +2 Active in the past year +1 Stable for at least 1 year 0 Stable for at least 1 year and spontaneous repigmentation -1

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)