MedPath

Evaluation of safety and the effectiveness of Bioba (Prime) anti-hair loss line (serum and shampoo)

Phase 2
Recruiting
Conditions
hair loss.
Nonscarring hair loss, unspecified
L65.9
Registration Number
IRCT20190210042676N16
Lead Sponsor
Akhavi laboratory
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
19
Inclusion Criteria

Male or female aged 18-55 years
Diffuse and scattered hair loss (Count at least 300 hairs in a combing test over three days)
General health
Voluntary participation and signing written informed consent

Exclusion Criteria

Chronic active scalp disease other than hair loss
Using any prescribed drug or OTC for hair loss within the past 3 months
Any severe weight loss or strict diet therapy during the study
Pregnancy or breastfeeding

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hair count changes. Timepoint: Before intervention, 6 and 12 weeks after the start of use. Method of measurement: Trichoscopy By Fotofinder.
Secondary Outcome Measures
NameTimeMethod
Hair lost Changes, based on Global photographic review. Timepoint: Before intervention, 6 and 12 weeks after the start of use. Method of measurement: One independent dermatologist will perform clinical assessments in a blinded fashion by scoring every photograph according to the Global photographic review scale .;Changes in percentage of anagen to telogen. Timepoint: Before intervention, 6 and 12 weeks the start of use. Method of measurement: Trichoscopy By Fotofinder.
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