DermatologyPhase 1/2NCT06333600
Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss
A Phase 1/2 study testing Topical minoxidil, Topical Vitamin D and Saline spray in people with Dermatology and Female Pattern Baldness, run by Sohag University at 1 site in Egypt.
Trial summary
The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases Read more about this study
- Who is it for?
- Ages 15 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dermatology, Female Pattern Baldness
- What is being tested?
- Topical minoxidil, Topical Vitamin D and Saline spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2023to 1 May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All females with FPHL aging 15 - 60 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Facult of Medicine, Sohag Uniiversity
Sohag, 82515
Doaa G Abdelbaset, MSc, 01022330810 ext. 002, dodygaber64@yahoo.com
Doaa G Abdelbaset, Msc, 01014733007 ext. 002, dodygaber64@yahoo.com
About this study
The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases
Read the 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:
- 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.
- Hair examination will include:
- Pattern of hair loss (Ludwig, Olsen or Norwood)
- Pull test
- Scalp skin condition
- Grading according to Sinclair scale
- 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
- Conditions
- Dermatology, Female Pattern Baldness
- Being tested
- Topical minoxidil, Topical Vitamin D, Saline spray
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical minoxidilDrug
Also called Rogaine
Therapeutic intervention
Topical Vitamin DDrug
Also called Calcipotriol
Therapeutic intervention
Saline sprayDrug
Also called saline
placebo
| Study group | Role | What they receive |
|---|---|---|
| Group minoxidil (Treatment group) | Active comparator | Topical application of Minoxidil 5% solution Receives: Drug: Topical minoxidil |
| Group calcipotriol (Treatment group) | Active comparator | Topical application of vitamin D3 analogue (Calcipotriol ointment) Receives: Drug: Topical Vitamin D |
| Group 3 (Negative control group) | Placebo comparator | This group will be given saline Receives: Drug: Saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Sinclaire grading of Female pattern hair loss
clinical grading of female pattern hair loss
Measured: 3 months
Change of Trichoscopic parameters (Hair dermoscopy)
Measure specific findings of female pattern hair loss diagnosis and follow up after treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start20 May 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatologyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Gaber Abdel baset, Sohag University
- Investigators
- Essam A Nada, MD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333600
- Sponsor's protocol ID
- Soh-Med-23-07-05
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss
- ClinicalTrials.gov ID
- NCT06333600
- Acronym / sponsor ID
- Soh-Med-23-07-05
- Conditions
- Dermatology, Female Pattern Baldness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Hair examination will include:
- Pattern of hair loss (Ludwig, Olsen or Norwood)
- Pull test
- Scalp skin condition
- Grading according to Sinclair scale
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group minoxidil (Treatment group) | Active comparator | Drug: Topical minoxidilTopical application of Minoxidil 5% solution |
| Group calcipotriol (Treatment group) | Active comparator | Drug: Topical Vitamin DTopical application of vitamin D3 analogue (Calcipotriol ointment) |
| Group 3 (Negative control group) | Placebo comparator | Drug: Saline sprayThis group will be given saline |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All females with FPHL aging 15 - 60 years
Key exclusion criteria (7 listed)
- Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical minoxidilAlso: RogaineTherapeutic intervention | Drug | Group minoxidil (Treatment group) |
| Topical Vitamin DAlso: CalcipotriolTherapeutic intervention | Drug | Group calcipotriol (Treatment group) |
| Saline sprayAlso: salineplacebo | Drug | Group 3 (Negative control group) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essam A Nada, MD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical minoxidil, Topical Vitamin D and Saline spray in people with Dermatology and Female Pattern Baldness, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa G Abdelbaset, MSc (0201022330810, dodygaber64@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Sinclaire grading of Female pattern hair loss (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.