Safety and efficacy study of a Hair Care Regimen consisting of Hair Oil, Shampoo, Hot Oil Treatment and Oil Replacement used in combination in treatment of hair fall control

Completed

• Conditions: 18 to 65 years adult female subjects having 50 to 100 hair fall per day.

• Registration Number: CTRI/2019/09/021018
• Lead Sponsor: Dabur International Limited

Brief Summary

Anopen-label, single-center, study to evaluate the safety and efficacy of a HairCare Regimen consisting of Hair Oil, Shampoo, Hot Oil Treatment and OilReplacement used in combination in treatment for hair fall control in healthyadult human subjects.

Total study duration is 90days i.e. 3 Months.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-09
• Study Completion: 2020-04-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• 1)Age: 18 to 65 years (both inclusive) at the time of consent.
• 2)Sex: Healthy non-pregnant/non-lactating females.
• 3)Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit.
• 4)Subjects generally in good health.
• 6)Females with 50 count of hair fall from hair combing method (60-sec hair count) at screening visit (if screening and enrollment on same day) or on enrollment day before treatment.
• 7)Subjects willing to give written informed consent and willing to follow study procedure.
• 8)Subjects who have used other marketed product for hair fall control in the past.
• 9)Subjects willing to refrain from any other treatment for the main indications for which the study test products are being given during the course of the study.
• 10)Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair fall treatment/ hair products other than the test product for the entire duration of the study.

Exclusion Criteria

• 1)Subjects with history of severe Hair fall due to any clinically significant problems/s like anaemia, thyroid problems etc.
• 2)History of any dermatological condition of the scalp other than hair loss and/or dandruff.
• 3)History of prior use of scalp hair growth treatment within 3 months.
• 4)History of any prior hair growth procedures (e.g., hair transplant or laser).
• 5)Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study.
• 6)History of alcohol or drug addiction.
• 7)Subjects using other marketed hair fall control products during the study period.
• 8)Subjects who have plans of shaving of scalp hair during the course of the study.
• 9)Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
• 10)History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
• 11)Subjects having a history or present condition of an allergic response to any cosmetic products.
• 12)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
• 13)Pregnant or breastfeeding or planning to become pregnant during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percentage change in hair fall reduction after 12 weeks of treatment from Baseline on Day 01 before treatment to Day 21, Day 45, Day 63 and Day 90 (±2 Days) after treatment using 60-S Hair count technique.	Baseline on Day 01 before treatment, after treatment on Day 21, Day 45, Day 63 and Day 90.

Secondary Outcome Measures

Name	Time	Method
1. Change in general appearance of hair (Hair Volume, Hair Density, Hair Plasticity, Hair strength, Hair smoothness, Hair Oiliness, Shininess), Change in appearance of scalp skin (itchiness, redness, roughness and scaliness of scalp), Change in hair shine, hair strength & hair frizziness, Measuring overall quality of hair i.e. Hair Thickness, Hair Density and Scalp condition & Product perception.	2. Measuring hair growth phase i.e. % anagen hairs, % telogen hairs and A:T ratio.

Trial Locations

Locations (1)

Cliantha Research; 🇮🇳 Ahmadabad, GUJARAT, India

Cliantha Research

🇮🇳Ahmadabad, GUJARAT, India

Dr Nayan Patel

Principal investigator

9909013286

nayan.patel@karmiclifesciences.com