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

NCT01662089 | Unknown Phase 1 DMC

• 1 other identifier: SirirajH-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Pattern Alopecia

Keywords

Female pattern hair loss

Outcome Measures

Primary Outcomes (3)

• Compare clinical improvement before and after treatment

  Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist

  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.

  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.

  6 month

Secondary Outcomes (1)

• Number of pateint with Side effect

  6 month

Study Arms (2)

Chelate zinc suppliment

EXPERIMENTAL

15mg Chelate zinc suppliment : additional to standard 5% minoxidil

Drug: 15 mg Chelate zinc supplement

Placebo drug

PLACEBO COMPARATOR

Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil

Drug: Placebo drug supplement

Interventions

15 mg Chelate zinc supplement DRUG

15 mg Chelate zinc additional to standard 5% minoxidil

Also known as: zinc, Zn

Chelate zinc suppliment

Placebo drug supplement DRUG

Placebo drug instead of Zinc supplement

Also known as: starch

Placebo drug

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Zinc; Starch

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Central Study Contacts

Rattapon Thuangtong, MD

CONTACT

+662 419-7000; rattapongthuangtong@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 10, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 10, 2012

Record last verified: 2012-08

Locations

TH (1)