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

• ClinicalTrials.gov Identifier: NCT06333600
• Recruitment Status: Recruiting
• First Posted: March 27, 2024
• Last Update Posted: March 27, 2024
• Sponsor: Sohag University
• Information provided by (Responsible Party): Doaa Gaber Abdel baset, Sohag University

Tracking Information

• First Submitted Date: March 4, 2024
• First Posted Date: March 27, 2024
• Last Update Posted Date: March 27, 2024
• Actual Study Start Date: May 20, 2023
• Estimated Primary Completion Date: April 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2024)

• Change of Sinclaire grading of Female pattern hair loss [ Time Frame: 3 months ]
  clinical grading of female pattern hair loss
• Change of Trichoscopic parameters (Hair dermoscopy) [ Time Frame: 3 months ]
  Measure specific findings of female pattern hair loss diagnosis and follow up after treatment

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss
• Official Title: Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss
• Brief Summary: The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases

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
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Dermatology
• Female Pattern Baldness

Intervention

• Drug: Topical minoxidil
  Therapeutic intervention
  Other Name: Rogaine
• Drug: Topical Vitamin D
  Therapeutic intervention
  Other Name: Calcipotriol
• Drug: Saline spray
  placebo
  Other Name: saline

Study Arms

• Active Comparator: Group minoxidil (Treatment group)
  Topical application of Minoxidil 5% solution
  Intervention: Drug: Topical minoxidil
• Active Comparator: Group calcipotriol (Treatment group)
  Topical application of vitamin D3 analogue (Calcipotriol ointment)
  Intervention: Drug: Topical Vitamin D
• Placebo Comparator: Group 3 (Negative control group)
  This group will be given saline
  Intervention: Drug: Saline spray

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 20, 2024): 45
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2024
• Estimated Primary Completion Date: April 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 15 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Doaa G Abdelbaset, MSc; 0201022330810; dodygaber64@yahoo.com

Contact: Doaa G Abdelbaset, MSc; 00201022330810; doaa.gaber@med.sohag.edu.eg

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT06333600
• Other Study ID Numbers: Soh-Med-23-07-05
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Doaa Gaber Abdel baset, Sohag University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sohag University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Essam A Nada, MD; Professor

• PRS Account: Sohag University
• Verification Date: March 2024