Female Pattern AlopeciaPhase 1/2NCT01662089
The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement
A Phase 1/2 study testing 15 mg Chelate zinc supplement in people with Female Pattern Alopecia, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient. But the type of patient, efficacy, and side effect in detail of zinc supplement are not well characterized. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Pattern Alopecia
- What is being tested?
- 15 mg Chelate zinc supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Dec 2012
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Pattern Hair Loss ( Ludwig classification grade 1 and 2 )
Who cannot join
- Underlying disease ; Anemia, Diabetes, chronic alcoholism, previous gastrointestinal surgery, short bowel syndrome, Crohn's disease, digestive disorder, hypo/hyperthyroidism, sickle cell disease, autoimmune disease, iron deficiency
- Psychologic disorder trichotillomania
- Diet control
- Pregnancy or lactation
- On supplement diet within 3 month prior to trial
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, 10700
Rattapon Thuangtong, MD, +662 419-7000 ext. 4333, rattapongthuangtong@yahoo.com
About this study
Official title: A Pilot Study of the Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Oral Chelated Zinc Supplement
Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient. But the type of patient, efficacy, and side effect in detail of zinc supplement are not well characterized. The purpose of this study is to determine efficacy and side effect of chelated zinc in FPHL who using 5%minoxidil solution.
Read the detailed description
5%minoxidil solution is standard treatment for Female pattern hair loss (FPHL) patient. We gave 15mg chelate Zinc / Placebo drug to patient as an additional trace element. Then measure growth of hair by Global photograph, Microscope hair count, micrometer and record case and side effect during 10 months of treatment.
- Conditions
- Female Pattern Alopecia
- Being tested
- 15 mg Chelate zinc supplement, Placebo drug supplement
- Keywords
- Female pattern hair loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 mg Chelate zinc supplementDrug
Also called zinc, Zn
15 mg Chelate zinc additional to standard 5% minoxidil
Placebo drug supplementDrug
Also called starch
Placebo drug instead of Zinc supplement
| Study group | Role | What they receive |
|---|---|---|
| Chelate zinc suppliment | Experimental | 15mg Chelate zinc suppliment : additional to standard 5% minoxidil Receives: Drug: 15 mg Chelate zinc supplement |
| Placebo drug | Placebo comparator | Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil Receives: Drug: Placebo drug supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare clinical improvement before and after treatment
Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist
Measured: 6 month
Compare hair density before and after treatmen
Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.
Measured: 6 month
Compare average hair shaft diameter before and after treatment
Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.
Measured: 6 month
Secondary outcomes (1)
Number of pateint with Side effect
Using side effect record form to record side effect from treatment Count number of pateint with side effect.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern AlopeciaStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rattapon Thuangtong, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662089
- Sponsor's protocol ID
- SirirajH-004
- Status last verified
- Aug 2012
- First submitted
- 5 Aug 2012
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Oral Chelated Zinc Supplement
- ClinicalTrials.gov ID
- NCT01662089
- Acronym / sponsor ID
- SirirajH-004
- Conditions
- Female Pattern Alopecia
- Keywords
- Female pattern hair loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Aug 2012 (estimated)
- 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.
Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient. But the type of patient, efficacy, and side effect in detail of zinc supplement are not well characterized. The purpose of this study is to determine efficacy and side effect of chelated zinc in FPHL who using 5%minoxidil solution.
Detailed description
5%minoxidil solution is standard treatment for Female pattern hair loss (FPHL) patient. We gave 15mg chelate Zinc / Placebo drug to patient as an additional trace element. Then measure growth of hair by Global photograph, Microscope hair count, micrometer and record case and side effect during 10 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chelate zinc suppliment | Experimental | Drug: 15 mg Chelate zinc supplement15mg Chelate zinc suppliment : additional to standard 5% minoxidil |
| Placebo drug | Placebo comparator | Drug: Placebo drug supplementPlacebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female Pattern Hair Loss ( Ludwig classification grade 1 and 2 )
Key exclusion criteria (5 listed)
- Underlying disease ; Anemia, Diabetes, chronic alcoholism, previous gastrointestinal surgery, short bowel syndrome, Crohn's disease, digestive disorder, hypo/hyperthyroidism, sickle cell disease, autoimmune disease, iron deficiency
- Psychologic disorder trichotillomania
- Diet control
- Pregnancy or lactation
- On supplement diet within 3 month prior to trial
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 |
|---|---|---|
| 15 mg Chelate zinc supplementAlso: zinc, Zn15 mg Chelate zinc additional to standard 5% minoxidil | Drug | Chelate zinc suppliment |
| Placebo drug supplementAlso: starchPlacebo drug instead of Zinc supplement | Drug | Placebo drug |
Primary outcome
Compare clinical improvement before and after treatment
Time frame: 6 month
Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist
Compare hair density before and after treatmen
Time frame: 6 month
Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.
Compare average hair shaft diameter before and after treatment
Time frame: 6 month
Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.
1 secondary outcome
Number of pateint with Side effect
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
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Oral Minoxidil With or Without a Multifactorial Drinkable Nutraceutical in Female Pattern Hair Loss: a Retrospective Study
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Dual Modality Treatment of Androgenic Alopecia With KeraFactor® Solution and Revian® LED Light Therapy
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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.
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 15 mg Chelate zinc supplement in people with Female Pattern Alopecia, run by Siriraj Hospital at 1 site in Thailand.
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 5 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 10 Aug 2012. 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 Thailand. 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 Rattapon Thuangtong, MD (+662 419-7000 ext. 4333, rattapongthuangtong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare clinical improvement before and after treatment (time frame: 6 month). The study lists 3 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 10 Aug 2012.