NCT03234673

Brief Summary

Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009). Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 27, 2017

Last Update Submit

July 30, 2017

Conditions

Vitiligo Vulgaris

Outcome Measures

Primary Outcomes (1)

  • 1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).

    G0, \< 25% repigmentation (poor) * G1, 25-50% repigmentation (fair) * G2, 50-75% repigmentation (good) * G3 \> 75% repigmentation (excellent).

    up to 3 months

Secondary Outcomes (1)

  • The VASI percent change

    every month for 3 months

Other Outcomes (2)

  • - Frequency and types of side effects.

    3 months

  • - Patient satisfaction. The patient overall satisfaction will be assessed after 6 months according to Wong and Vasconez (2011). Overall satisfaction:

    3 months

Study Arms (3)

Group A (Tacrolimus group):

EXPERIMENTAL

fractional CO2 laser therapy and Tacrolimus ointment 1

Drug: Tacrolimus ointment

Group B (Calcipotriol group):

EXPERIMENTAL

fractional CO2 laser therapy and Calcipotriol ointment

Drug: calcipotriol ointment

Group C (NB-UVB group):

EXPERIMENTAL

fractional CO2 laser therapy and NB-UVB twice weekly

Drug: NB-UVB

Interventions

Tacrolimus ointmentDRUG

3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.

Also known as: tarolimus ointment
Group A (Tacrolimus group):
calcipotriol ointmentDRUG

3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.

Also known as: calcipoheal
Group B (Calcipotriol group):
NB-UVBDRUG

3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months

Also known as: narrow band ultraviolet rays B
Group C (NB-UVB group):

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with stable vitiligo
  • nonsegmental vitiligo will be recruited
  • A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year

You may not qualify if:

  • Patients with active infection.
  • Reported histories of koebnerization.
  • History of keloid formation or hypertrophic scars.
  • Pregnant or lactating females.
  • Bleeding tendency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.

    PMID: 25596811RESULT

  • Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944.

    PMID: 23919018RESULT

  • Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8.

    PMID: 19787413RESULT

  • Wong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e.

    PMID: 21451378RESULT

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

yasmin tawfik, MD

CONTACT

01006033331dr.yasminmostawfik@yahoo.com

reham maher abdel gaber

CONTACT

01005043777rehamaher707@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

July 27, 2017

First Posted

July 31, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

January 1, 2019

Last Updated

August 1, 2017

Record last verified: 2017-07