The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement

Female Pattern Alopecia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01662089
• Other study ID #: SirirajH-004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 5, 2012
• Last updated: August 7, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Siriraj Hospital
• Contact: Rattapon Thuangtong, MD
• Phone: +662 419-7000
• Email: rattapongthuangtong[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical 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. The purpose of this study is to determine efficacy and side effect of chelated zinc in FPHL who using 5%minoxidil solution.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female Pattern Hair Loss ( Ludwig classification grade 1 and 2 )

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Female Pattern Alopecia

Intervention

Drug:
• 15 mg Chelate zinc supplement
15 mg Chelate zinc additional to standard 5% minoxidil
• Placebo drug supplement
Placebo drug instead of Zinc supplement

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare clinical improvement before and after treatment	Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist	6 month	No
Primary	Compare hair density before and after treatmen	Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.	6 month	No
Primary	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.	6 month	No
Secondary	Number of pateint with Side effect	Using side effect record form to record side effect from treatment Count number of pateint with side effect.	6 month	Yes