Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss

NCT06333600 | Recruiting Phase 1 DMC

• 1 other identifier: Soh-Med-23-07-05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases

Conditions

Dermatology; Female Pattern Baldness

Outcome Measures

Primary Outcomes (2)

• Change of Sinclaire grading of Female pattern hair loss

  clinical grading of female pattern hair loss

  3 months

• Change of Trichoscopic parameters (Hair dermoscopy)

  Measure specific findings of female pattern hair loss diagnosis and follow up after treatment

  3 months

Study Arms (3)

Group minoxidil (Treatment group)

ACTIVE COMPARATOR

Topical application of Minoxidil 5% solution

Drug: Topical minoxidil

Group calcipotriol (Treatment group)

ACTIVE COMPARATOR

Topical application of vitamin D3 analogue (Calcipotriol ointment)

Drug: Topical Vitamin D

Group 3 (Negative control group)

PLACEBO COMPARATOR

This group will be given saline

Drug: Saline spray

Interventions

Topical minoxidil DRUG

Therapeutic intervention

Also known as: Rogaine

Group minoxidil (Treatment group)

Topical Vitamin D DRUG

Therapeutic intervention

Also known as: Calcipotriol

Group calcipotriol (Treatment group)

Saline spray DRUG

placebo

Also known as: saline

Group 3 (Negative control group)

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All females with FPHL aging 15 - 60 years

You may not qualify if:

• Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
• Patients with normal serum vit.D level
• Oral or parentral vitamin D supplementation for the last 3 months
• Treatment with topical vitamin D analogs in the past month
• Patients who received hair tonics or any specific hair therapy over the last 3 months prior to enrollement in the study.
• Patients with diabetes mellitus, renal disease, thyroid and parathyroid abnormalities, or autoimmune diseases.
• Patients who are pregnant, lactating or on contraceptive pills.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Facult of Medicine, Sohag Uniiversity

Sohag, 82515, Egypt

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Vitamin D; calcipotriene; Sodium Chloride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Essam A Nada, MD

  Professor

  STUDY CHAIR

Central Study Contacts

Doaa G Abdelbaset, MSc

CONTACT

0201022330810; dodygaber64@yahoo.com

Doaa G Abdelbaset, MSc

CONTACT

00201022330810; doaa.gaber@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 27, 2024
• Study Start: May 20, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)