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

Phase 1

• Conditions: Female Pattern Alopecia
• Interventions: Drug: 15 mg Chelate zinc supplement; Drug: Placebo drug supplement

• Registration Number: NCT01662089
• Lead Sponsor: Siriraj Hospital

Brief 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.

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 Timeline

• Study Start: 2012-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-05
• Study First Submitted QC: 2012-08-07
• Last Update Submitted: 2012-08-07
• Study First Posted: 2012-08-10
• Last Update Posted: 2012-08-10
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chelate zinc suppliment	15 mg Chelate zinc supplement	15mg Chelate zinc suppliment : additional to standard 5% minoxidil
Placebo drug	Placebo drug supplement	Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil

Primary Outcome Measures

Name	Time	Method
Compare clinical improvement before and after treatment	6 month	Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist
Compare hair density before and after treatmen	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	6 month	Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.

Secondary Outcome Measures

Name	Time	Method
Number of pateint with Side effect	6 month	Using side effect record form to record side effect from treatment Count number of pateint with side effect.

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand