Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333600
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-04
Brief Title:
Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 vitD 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 0005 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 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 vitD 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 0005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None