NCT04245319

Brief Summary

Since abnormal keratinocyte (KC) 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

January 21, 2020

Last Update Submit

July 17, 2021

Conditions

HyperlipidemiasXerosisDepressionLiver Diseases

Outcome Measures

Primary Outcomes (2)

  • Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index

    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)

    4-5 months

  • Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score.

    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).

    4-5 months

Study Arms (2)

NbUVB

OTHER

Group A: patients will receive three NB-UVB sessions per week for 48 sessions.

Other: Narrow band ultraviolet B

Combined nbUVB and Acitretin

EXPERIMENTAL

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

Drug: AcitretinOther: Narrow band ultraviolet B

Interventions

AcitretinDRUG

The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed

Also known as: Acitretin 25Mg Cap, Acitretin 10Mg Cap
Combined nbUVB and Acitretin
Narrow band ultraviolet BOTHER

Patients receive nbUVB session 3 times per week

Combined nbUVB and AcitretinNbUVB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

HyperlipidemiasDepressionLiver Diseases

Interventions

AcitretinCapsules

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavioral SymptomsBehaviorDigestive System Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological FactorsDosage FormsPharmaceutical Preparations

Central Study Contacts

Noha A. Saleh, M.Sc

CONTACT

+201222177210noushy2938@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 mg/kg/day daily.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

January 1, 2020

Primary Completion

November 30, 2021

Study Completion

December 1, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)