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Combined Effect of Acitretin and nbUVB on Vitiligo Repigmentation

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ClinicalTrials.gov Identifier: NCT04245319
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Shahira Ramadan, Cairo University

Brief Summary:
Since abnormal keratinocyte proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of adhesion molecules, with narrowband UVB in the treatment of vitiligo.

Condition or disease Intervention/treatment Phase
Hyperlipidemias Xerosis Depression Liver Diseases Drug: Acitretin Other: Narrow band ultraviolet B Not Applicable

Detailed Description:

• Twenty patients with generalized vitiligo will be included in this study.

All patients will be subjected to:

  • Clinical evaluation:
  • An informed written consent.
  • History taking include age, previous treatment, disease activity
  • Clinical examination including Vitiligo Area Scoring Index (VASI) and Vitiligo Disease Activity Score (VIDA)
  • Photography (before starting the treatment and every 2 weeks till the end of the study)

Laboratory evaluation:

  • 2 mm punch skin biopsies will be taken from vitiligo patients, 1 from lesional and the other from perilesional skin before treatment.
  • The patients will be randomly assigned to two groups:

Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3-0.5 mg/kg/day daily.

  • Controls: 20 individuals age and sex matched will be biopsied from the skin of their abdominoplasty surgery.
  • Another two 2 mm punch skin biopsies will be taken from lesional and perilesional skin at the onset of repigmentation if repigmentation starts before completion of the 48 treatment session or after completion of the treatment period if repigmentation does not occur.
  • .All biopsies from patients and controls will be stained Immunohistochemically by anti-E cadherin antibody.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3-0.5 mg/kg/day daily.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Combined Effect of Acitretin and Narrow Band Ultraviolet B on the Clinical Repigmentation and on the Expression of E-cadherins in Vitiligo Lesions in Comparison to Narrow Band UVB Alone. A Pilot Study
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo
Drug Information available for: Acitretin

Arm Intervention/treatment
NbUVB
Group A: patients will receive three NB-UVB sessions per week for 48 sessions.
Other: Narrow band ultraviolet B
Patients receive nbUVB session 3 times per week

Experimental: Combined nbUVB and Acitretin
Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3-0.5 mg/kg/day daily.
Drug: Acitretin
The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed
Other Names:
  • Acitretin 25Mg Cap
  • Acitretin 10Mg Cap

Other: Narrow band ultraviolet B
Patients receive nbUVB session 3 times per week




Primary Outcome Measures :
  1. Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index [ Time Frame: 4-5 months ]
    The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Area Scoring Index (VASI)

  2. Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score. [ Time Frame: 4-5 months ]
    The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Disease Activity Score (VIDA).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with generalized non-segmental vitiligo (25%-75%)
  • Males, postmenopausal females and premenopausal females not planning to get pregnant during the period of treatment and after 2 years from the end of treatment.
  • Age more than 18 years.

Exclusion Criteria:

  • Children ˂ 18 years old
  • Pregnant females
  • Premenopausal females planning to get pregnant within the period of treatment or within 2 years after.
  • Patients receiving treatment for vitiligo within the past 2 months.
  • Patients with abnormal liver profile
  • Patients with abnormal lipid profile
  • Patients with associated photosensitive disorders
  • Patients having associated skin diseases other than vitiligo
  • Cataract and aphakia
  • High cumulative dose from previous sessions of narrowband ˃ 200-300 session

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): NCT04245319


Contacts
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Contact: Noha A. Saleh, M.Sc +201222177210 noushy2938@gmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 11956
Sponsors and Collaborators
Cairo University
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Responsible Party: Shahira Ramadan, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT04245319    
Other Study ID Numbers: Acitretin in vitiligo
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Vitiligo
Hyperlipidemias
Digestive System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Acitretin
Keratolytic Agents
Dermatologic Agents