Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata

Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial

Alopecia Areata is a common condition. This study investigated the efficacy of calcipotriol versus Narrow Band Ultraviolet B in treatment of Alopecia areata and their effects on serum vitamin D3 levels.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Calcipotriol; Diagnostic test: vitamin D3 level; Device: Narrow Band UVB

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Alopecia Areata of scalp

Exclusion Criteria:

Other causes of alopecias including scarring alopecia, androgenic alopecia, telogen effluvium autoimmune diseases, pregnant and lactating females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group II	Diagnostic test: vitamin D3 level; vitamin D3 (ng/ml); Device: Narrow Band UVB; NB-UVB (311nm) phototherapy
Active Comparator: Group III	Drug: Calcipotriol; Calcipotriol ointment (0.005%); Diagnostic test: vitamin D3 level; vitamin D3 (ng/ml); Device: Narrow Band UVB; NB-UVB (311nm) phototherapy
Active Comparator: Group I	Drug: Calcipotriol; Calcipotriol ointment (0.005%); Diagnostic test: vitamin D3 level; vitamin D3 (ng/ml)
Placebo Comparator: Group IV	Diagnostic test: vitamin D3 level; vitamin D3 (ng/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score	calculation of SALT score before and after treatment	3 months
Improvement of serum Vitamin D levels in (ng/ml) after treatment	measurement of serum vitamin D before and after treatment	3 months

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Vitamin D3; Alopecia Areata; Calcipotriol; Narrow Band-UVB
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Dermatologic Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Calcipotriene
• Other Study ID Numbers: Alopecia Calcipotiol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No