To evaluate in vivo safety and efficacy of hair care formulation in terms of hair growth i.e., improvement in A is to T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength on healthy human subjects.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Improvement in A:T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength
Study Overview
Brief Summary
OBJECTIVE : The objective of this study will be to evaluate in-vivo safety and efficacy of hair care formulation in terms of hair growth i.e., improvement in A:T ratio, improvement in hair density, reduction in hair fall and improvement in hair strengthon healthy human subjects The evaluation will be performed using: Subject’s self-assessment questionnaire, Dermatological evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Phototrichogram Analysis, Analysis of hair thickness through Dino-lite Digital Microscope, Counting of Fallen Hair after Standardized Combing
POPULATION : 36 (18 male and 18 female) subjects are selected for the study.The subjects selected for this study are healthy males & females aged between 30 and 50 years & showing initial stage of baldness, For Males: Hamilton Scale Class II to III (including III, IIIA and III vertex) ; for Females: Ludwig Scale I-2 to I-4). STUDY DURATION : 84 days following the first application of the product.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Indian or Asian male & female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Having androgenetic alopecia of class I-2 to I-4 according to Ludwig Scale for females and class II to III (including III, IIIA and III vertex) according to Norwood Hamilton Scale for males.
Exclusion Criteria
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
- •Having cutaneous hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
Outcomes
Primary Outcomes
Improvement in A:T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength
Time Frame: Baseline, 28 Days, 56 Days, 84Days
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.