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

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

Study Overview

• Status: Recruiting
• Conditions: Female Pattern Baldness; Dermatology
• Intervention / Treatment: Drug: Topical minoxidil; Drug: Topical Vitamin D; Drug: Saline spray

Detailed Description

Study approval: The study will be approved by Research and Ethical committee at Faculty of Medicine, Sohag University. Informed written consent will be obtained from all participants after explanation of nature of the study.

Study design: A prospective, randomized, controlled clinical study. Study population: The study will include 45 females aged 15-70 years attending Dermatology outpatient clinic at Sohag University Hospital with a complaint of chronic diffuse hair loss diagnosed clinically and will be confirmed by trichoscope as FPHL and with serum vitamin D deficiency.

Exclusion criteria will include:

• Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
• 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.

All patients in this study will be subjected to:

1. Complete history including:

   • Personal history: age, occupation, residence, marital status, special habits of medical importance
   • Menstrual and obstetric history
   • Average time spent outdoor (per hour)
   • Diatery habits
   • Family history of similar condition
   • History of any chronic illness or hormonal abnormalities such as hirsutism, PCO…..
   • History of hair loss including: age of onset, course, duration, affected site and any previous treatment taken by the patient and its response.

2. Hair examination will include:

   • Pattern of hair loss (Ludwig, Olsen or Norwood)
   • Pull test
   • Scalp skin condition
   • Grading according to Sinclair scale

3. Evaluating tools:

   • Gross photos will be taken under adequate illumination, identical settings, lighting, and position before starting treatment and at monthly follow up visits.
   • Trichoscopic examination: All cases will be viewed trichoscopically from frontal, temporal, and occipital views (before treatment and at follow up visits) and will be evaluated by two blinded investigators. Establishing the diagnosis of FPHL will be done according to diagnostic criteria of FPHL. Hair density, hair diameter and peripilar sign will be recorded before and after treatment.
   • Subject assessment: A 7-point scale will be used Investigations:-
   • Serum vit.D will be measured for all participants • Other investigations will be done if needed according to primary patient evaluation: CBC, serum ferritin, serum calcium level, serum creatinine, hormonal (TSH, FSH, LH, prolactin, testosterone).

Therapeutic interventions:- 45 patients diagnosed as FPHL with decreased serum vitamin D will be randomly divided into 3 treatment groups:

• Group 1 (15 patients) will apply topical 5% minoxidil solution in a dose of 1ml twice daily.
• Group 2 (15 patients) will apply topical vit. D analogue (calcipotriol ointment 0.005%) twice daily (1 fingertip unit for every 2% of body surface area)
• Group 3 (15 patients) ( placebo group).
• Any side effects will be registered such as itching, scalling, burning sensation, dryness….
• Duration of treatment will continue for 3 months

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Doaa G Abdelbaset, MSc; Phone Number: 0201022330810; Email: dodygaber64@yahoo.com
• Study Contact Backup: Name: Doaa G Abdelbaset, MSc; Phone Number: 00201022330810; Email: doaa.gaber@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 82515
    • Recruiting
    • Facult of Medicine, Sohag Uniiversity
    • Contact: Doaa G Abdelbaset, MSc; Phone Number: 002 01022330810; Email: dodygaber64@yahoo.com
    • Contact: Doaa G Abdelbaset, Msc; Phone Number: 002 01014733007; Email: dodygaber64@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All females with FPHL aging 15 - 60 years

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group minoxidil (Treatment group); Topical application of Minoxidil 5% solution	Drug: Topical minoxidil; Therapeutic intervention; Other Names: Rogaine
Active Comparator: Group calcipotriol (Treatment group); Topical application of vitamin D3 analogue (Calcipotriol ointment)	Drug: Topical Vitamin D; Therapeutic intervention; Other Names: Calcipotriol
Placebo Comparator: Group 3 (Negative control group); This group will be given saline	Drug: Saline spray; placebo; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: Essam A Nada, MD, professor

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Physiological Effects of Drugs; Antihypertensive Agents; Vasodilator Agents; Dermatologic Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Calcipotriene; Minoxidil
• Other Study ID Numbers: Soh-Med-23-07-05

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