Effect of the test product on dandruff control

Phase 2

Not yet recruiting

• Conditions: having Dandruff (Dharunaka)

• Registration Number: CTRI/2023/09/057704
• Lead Sponsor: Hindustan Unilever Limited

Brief Summary

**The objective of the present clinical study is to investigate the efficacy of test products in controlling dandruff condition. Study volunteers will be selected basis inclusion and exclusion criteria. Post informed consent, volunteers will be enrolled into the study and undergo 2 weeks of wash off period. Subjects are provided with the test product and usage instructions will be provided. Volunteers will visit the venue and dermatological and instrumental assessments will be performed at week 1, week 2 and week 4.   Test product treatment duration is 4 weeks, followed by  1 week of regression period.**

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-13
• Study Start: 2023-09-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Volunteer presenting moderate to severe dandruff (at least shoulder length hair for females) as per dermatological assessment.
• Volunteer in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
• Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
• Volunteers agreeing to comply with following study restrictions: -Volunteers Willing to refrain from application of any other product/treatment on their scalp and hair shafts during the study period.
• Not to apply any cosmetic, hair care product, test product and/or water 48 hours before scheduled visits.
• Willing not to colour or dye their hair just before the study visits and during the study period.

Exclusion Criteria

• Volunteer pregnant or planning to become pregnant.
• Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
• Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
• Volunteers with self-perceived sensitive skin.
• Volunteers having chronic illness or had major surgery in the last year.
• Volunteers undergoing any treatment of any skin condition on body.
• Volunteers taking medication continuously/regularly every day such as corticosteroids or non-steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the study.
• Volunteers taking medication for any condition which the Investigator believes may influence the interpretation of the data.
• Volunteers on food supplements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant reduction in dandruff flakes	Basline, Week 1, Week 2, Week 4. Week 5

Secondary Outcome Measures

Name	Time	Method
Significant reduction in scalp itch	Basline, Week 1, Week 2, Week 4. Week 5

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Raji Patil

Principal investigator

02243349191

raji@mascotspincontrol.in