The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo

July 30, 2017 updated by: Yasmin Mostafa Tawfik, Assiut University

The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013).

Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Patients with active infection.
  2. Reported histories of koebnerization.
  3. History of keloid formation or hypertrophic scars.
  4. Pregnant or lactating females.
  5. Bleeding tendency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Tacrolimus group):
fractional CO2 laser therapy and Tacrolimus ointment 1
Drug: Tacrolimus ointment
3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.
Other Names:
  • tarolimus ointment
Experimental: Group B (Calcipotriol group):
fractional CO2 laser therapy and Calcipotriol ointment
Drug: calcipotriol ointment
3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.
Other Names:
  • calcipoheal
Experimental: Group C (NB-UVB group):
fractional CO2 laser therapy and NB-UVB twice weekly
Drug: NB-UVB
3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months
Other Names:
  • narrow band ultraviolet rays B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).
Time Frame: up to 3 months

G0, < 25% repigmentation (poor)

  • G1, 25-50% repigmentation (fair)
  • G2, 50-75% repigmentation (good)
  • G3 > 75% repigmentation (excellent).
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The VASI percent change
Time Frame: every month for 3 months
The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score.
every month for 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Frequency and types of side effects.
Time Frame: 3 months
pain, scarring, hyperpigmentation
3 months
- Patient satisfaction. The patient overall satisfaction will be assessed after 6 months according to Wong and Vasconez (2011). Overall satisfaction:
Time Frame: 3 months
  1. dissatisfied
  2. neutral
  3. somewhat satisfied
  4. moderately satisfied
  5. very satisfied
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (Actual)

July 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 30, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEOPFCLEWTCOWNITTOSGV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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