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Contribution of Skin Color in Stabilization of Active Cases of Vitiligo by Narrow Band UVB

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ClinicalTrials.gov Identifier: NCT04030988
Recruitment Status : Unknown
Verified July 2019 by Mahy El-Bassiouny, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Cairo University
Menia University
Suez Canal University
Assiut University
Alexandria University
Information provided by (Responsible Party):
Mahy El-Bassiouny, Ain Shams University

Brief Summary:

Vitiligo is a disease in which autoimmunity plays a major role. Multiple treatment options are available, of which narrow-band UVB is a cornerstone, acting through immunosuppression and repigmentation by stimulating reservoir melanocytes.

It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier.


Condition or disease Intervention/treatment Phase
Vitiligo Drug: Oral dexamethasone minipulse Drug: Placebo oral tablet Phase 1

Detailed Description:

Vitiligo is acquired depigmentation disorder. Several theories were hypothesized for causing vitiligo, of which the autoimmune theory is the most accepted.

The main targets of therapy are stabilization of the disease activity through immunosuppression, and repigmentation through stimulation of reservoir melanocytes proliferation and migration.

Narrow band ultraviolet phototherapy (NB-UVB) remains the cornerstone treatment of vitiligo. NB-UVB can induce both immunosuppression and repigmentation. Several factors can modulate the efficacy of NB-UVB therapy in treatment of vitiligo cases, including patient's age, lesion site, duration of the disease, and duration of the therapy.

The immunosuppressive function of NB-UVB was first detected in 1963 by Hanisko and Suskind, who observed that the contact hypersensitivity response in skin sensitized to dinitrochlorobenzene (DNCB) was reduced if skin was previously exposed to suberythemal doses of UVB.

Present evidence suggests that UVB suppress immune system through generation of T-suppressor cells, which inhibit the effector cells of Th1 type. It appears that UV-induced immunosuppression depresses the function of Th1 cells and enhances the activity of Th2 cells via cytokines such as Interleukin 10.

It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier. However, skin was previously divided to UVB-resistant and UVB-sensitive (UVB-R and UVB-S) based on the contact hypersensitivity testing, regardless of the skin type. Moreover, A study on NB-UVB phototherapy for psoriasis revealed that photoadaptation during NB-UVB therapy Is Independent of skin type.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 100 patients with non-segmental vitiligo are randomized to either NB-UVB therapy with placebo versus NB-UVB combined with mini-oral pulse steroids therapy. Vitligo activity will be assessed according to the VIDA scoring system. Skin type, extent of vitiligo using VES score, photography of all areas according to the VES areas at a fixed distance of 50 cm from the patient, and using a 1 cm diameter circular white sticker for reference later will be done. All patients will receive NB-UVB phototherapy at starting dose of 0.3 J/cm2, 3 times per week for 6 months (72 sessions) with gradually increasing increments according until faint erythema is attained at which point the dose is fixed. 100 patients will be randomized into 2 groups; 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week while the other 50 patients will receive placebo having the same color, form and packaging for 6 months.
Masking: Single (Care Provider)
Masking Description:

Masking involves only oral therapy; 100 patients will be randomized into 2 groups; 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week while the other 50 patients will receive placebo having the same color, form and packaging for 6 months.

The investigators are blinded.

Primary Purpose: Treatment
Official Title: The Reflection of Skin Color on the Efficacy of Narrow Band UVB in Stabilization of Active Cases of Vitiligo
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Active Comparator: Active
50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.
Drug: Oral dexamethasone minipulse
50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.
Other Name: Narrow band UVB

Placebo Comparator: Placebo
50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.
Drug: Placebo oral tablet
50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments
Other Name: Narrow band UVB




Primary Outcome Measures :
  1. Detecting number of participants with clinical activity of vitiligo [ Time Frame: At 6 months after treatment. ]
    Appearance of new lesions or expansion of pre-existing lesions by clinical examination.

  2. Photography to detect activity of vitiligo [ Time Frame: Change from baseline (first visit) at 6 months after treatment. ]
    New lesions in each area will be counted.

  3. Elevation of serum Vitiligo activity markers. [ Time Frame: Change from baseline at 6 months after treatment. ]

    A 5 cc blood sample will be withdrawn from each patient for:

    ELISA assessment of CXCL-10 (Pg/ml)


  4. Elevation of PCR levels of serum Vitiligo activity markers [ Time Frame: Change from baseline at 6 months after treatment. ]

    A 5 cc blood sample will be withdrawn from each patient for:

    PCR assessment of m-RNA of CXCL-10 as markers of disease activity.




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active cases of non-segmental vitiligo, VIDA +2 or more.
  • All skin types
  • Age above 6 years, both sexes.

Exclusion Criteria:

  • Contraindications to NB-UVB ( photosensitive skin disorders, skin malignancy, patients on photosensitizing medications)
  • Contraindications to mini-pulse steroid therapy (uncontrolled diabetes or hypertension, peptic ulcer)
  • Stable disease (VIDA 0 & -1) and activity more than 6 months ago (VIDA +1).
  • The use of other treatment for vitiligo during the 3 months previous to enrollment.

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): NCT04030988


Contacts
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Contact: Mahy ElBassiouny, Ass.Lecturer 002 01002202651 mahyelbasyouni@gmail.com
Contact: Marwa Abdallah, Professor 002 01001166299 marwa_abdallah@hotmail.com

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Abbaseya, Egypt, 00202
Contact: Mahy ElBassiouny, Ass.Lecturer    002 01002202651    mahyelbasyouni@gmail.com   
Contact: Marwa Abdallah, Professor    002 01001166299    marwa_abdallah@hotmail.com   
Sponsors and Collaborators
Ain Shams University
Cairo University
Menia University
Suez Canal University
Assiut University
Alexandria University
Investigators
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Principal Investigator: Mahy ElBassiouny, Ass.Lecturer Ain Shams University
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Responsible Party: Mahy El-Bassiouny, Assistant Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT04030988    
Other Study ID Numbers: u4xjkivz
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Methodology and outcome of the study is palnned to be published in an international medical journal with sharing participants data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mahy El-Bassiouny, Ain Shams University:
Vitiligo
Narrow-band UVB
Skin color
Minipulse
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents