To evaluate the efficacy of antidandruff hair leave on product on healthy human subjects

Completed

• Conditions: Male and Female with Moderate to Severe dandruff

• Registration Number: CTRI/2018/05/013774
• Lead Sponsor: ITC Life Science and Technology Centre

Brief Summary

primary Objective - To study the efficacy of test product in conferring superior reduction in dandruff symptoms and related discomfort compared to the reference product , to study the efficacy  of test product in retarding / delaying dandruff recurrence compared to the reference product , to study the efficacy of the test product in conferring superior hair quality and scalp health compared to the reference product .

secondary objective - To study the tolerability and efficacy of the test products in conferring improved scalp health and hair attribute benefits.



sample size - Total of 50 healthy human adult subjects : male and female with moderate to severe dandruff.



study duration : Approximately 10 weeks for each subject.



study visits : Total 19 visits



study design : A controlled , parallel , comparative , randomized double blind study half head application design .



Main assessment parameters : dermatological visual assessment , black card assessment of falling flakes , hair fall count , and subject self assessment .



Results:The superior reduction in dandruff symptoms and related discomfort compared to the reference product wa observed. The retarding / delaying dandruff recurrence compared to the reference product was observed in some subjects. The iprovement in hair quality and scalp was observed in female subjects.The test product was well accepted by subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-25
• Study Completion: 2014-12-12
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Subjects who are willing to give signed informed consent and who consent to abide by the study protocol and restrictions for the entire study duration.
• 2.A mixed population of healthy male and female subjects in the age group of 20-45 yrs.
• 3.Subjects with preferably lengthy hair (for female subjects) but not mandatory.
• 4.Subjects with moderate to severe scalp dandruff score (with dandruff on both sides of the scalp).
• 5.Subjects with moderate to severe scalp itch score (Scoring based on subject’s feedback) 6.Subjects who have not participated in a similar investigation in the past four weeks.
• 7.Subjects who are not sensitive to the ingredients of the test product (As disclosed by the subjects or as observed during the Skin sensitivity test).

Exclusion Criteria

• 1.Subjects with a known history or present condition of allergic response to any shampoo or conditioner.
• 2.Subjects having communicable skin/scalp infections or other skin disease (e.g. psoriasis, atomic dermatitis or other cutaneous manifestations), which could interfere with the test results as diagnosed by Dermatologist.
• 3.Subjects with severe hair fall due to endocrine disorders as diagnosed by dermatologist or revealed through oral interview.
• 4.Subjects on medications (steroids, antihistamines, antimicrobials), which would compromise the study results (Subjects inputs).
• 5.Female subjects who are pregnant (determined by Urine pregnancy test), lactating, or planning pregnancy during the course of the study (Subjects inputs).
• 6.Subjects with signs and symptoms of systemic and / or chronic illness (As diagnosed by Dermatologist) 7.Subjects who are regular users of anti- dandruff shampoo/ undergoing therapy for dandruff (Subjects inputs).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Significant difference between the test products in conferring a reduction in dandruff symptoms.	Approximately 10 Weeks for each subjects
-Significant difference between the test products in delaying the recurrence of dandruff symptoms.	Approximately 10 Weeks for each subjects
-Significant difference between the test products in conferring improvement in hair quality and scalp health.	Approximately 10 Weeks for each subjects

Secondary Outcome Measures

Name	Time	Method
-No significant difference between the test products in tolerability and efficacy in conferring scalp and hair attribute benefits.	Approximately 10 Weeks for each subjct.

Trial Locations

Locations (1)

M.S Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

M.S Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

DrMukesh Ramnane

Principal investigator

080-40917253

mukesh.ramnane@mscr.in