To evaluate the dermatological safety of hair oil and shampoo on women with sensitive scalp conditions.

Phase 2/3

Completed

• Conditions: Total 35 female subjects, from 19 to 35 years (both inclusive) of age, with sensitive scalp condition were enrolled in the study

• Registration Number: CTRI/2018/01/011454
• Lead Sponsor: Dabur India Limited

Brief Summary

The clinical study was initiated for estimation of the overall dermatological safety of product regimen [Vatika B&B Shampoo (VBB01) and Vatika B&B Hair Oil (VBB02)]. 

35 healthy female subjects (with sensitive scalp condition), between 19 to 35 years of age (both inclusive), were enrolled in the study and all 35 respondent subjects completed the study. Subjects were screened basis predefined inclusion and exclusion criteria and were called for dermatological observations and subject self-assessment at week 0, week 2 and week 4.

Based on the results, test products were found to be overall dermatologically safe. Parameters evaluated were subject self-assessed and dermatological observed, which included safety parameters (burning, itching, stinging and redness) and overall scalp condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-31
• Study Completion: 2015-04-03
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• 1. Volunteer in generally in good health.
• 2. Volunteer with sensitive scalp condition.
• 3. Healthy female volunteer between 19 to 35 years of age (both inclusive) 4) Volunteer willing to give a written informed consent and come for regular observation.
• 5. The volunteer has not participated in a similar clinical investigation in the same past four weeks.

Exclusion Criteria

• 1. A known history or present condition of an allergic response to any cosmetic products.
• 2. Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
• 3. Medications (e.g. Steroids or antihistamines), which would compromise the study.
• 4. Pregnant or lactating.
• 5. Volunteer viewed by the investigator as not being able to complete the study or participating in another study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of the Product Regimen (shampoo & oil) on healthy human female subjects with sensitive scalp condition.	Screening, week 0, week 2 and week 4.

Secondary Outcome Measures

Name	Time	Method
To evaluate overall safety of the subject throughout the study.	Screening, week 0, week 2 and week 4.

Trial Locations

Locations (1)

Kelkar Education Trusts, Scientific Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Kelkar Education Trusts, Scientific Research Centre

🇮🇳Mumbai, MAHARASHTRA, India

Vihanga Khanna

Principal investigator

022-25639644

vihanga@kelkarcosmetology.com