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

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ClinicalTrials.gov Identifier: NCT03234673
Recruitment Status : Not yet recruiting
First Posted : July 31, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Yasmin Mostafa Tawfik, Assiut University

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).


Condition or disease Intervention/treatment Phase
Vitiligo Vulgaris Drug: Tacrolimus ointment Drug: calcipotriol ointment Drug: NB-UVB Phase 1

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

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 Name: 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 Name: 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 Name: narrow band ultraviolet rays B




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. - Frequency and types of side effects. [ Time Frame: 3 months ]
    pain, scarring, hyperpigmentation

  2. - 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



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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234673


Contacts
Contact: yasmin tawfik, MD 01006033331 dr.yasminmostawfik@yahoo.com
Contact: reham maher abdel gaber 01005043777 rehamaher707@yahoo.com

Sponsors and Collaborators
Assiut University

Publications of Results:
Responsible Party: Yasmin Mostafa Tawfik, clinical professor, Assiut University
ClinicalTrials.gov Identifier: NCT03234673     History of Changes
Other Study ID Numbers: TEOPFCLEWTCOWNITTOSGV
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Tacrolimus
Calcipotriene
Calcitriol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents