MedPath

Hair Benefit Study For The Test Products

Completed
Conditions
Dharunaka
Registration Number
CTRI/2021/09/036928
Lead Sponsor
Unilever Industries Pvt Ltd
Brief Summary

Study will be conducted to assess the efficacy of test product in imparting hair dandruff benefits. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Post baseline assessments, test product will be dispensed to subjects as per randomization and subjects will be instructed to use the product thrice a week and evaluation assessments will be done at different times points over a period of 6 weeks.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
220
Inclusion Criteria
  • 1.Female and male subjects in the ratio of 2:1 in general good health.
  • 2.Subjects in the age group 18-42 years (both the ages inclusive).
  • 3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
  • 4.Subjects willing to abide by and comply with the study protocol.
  • 5.Subjects who have not participated in a similar investigation in the past three months.
  • 6.Subjects who agree to refrain from using hair dye / hair colour /henna during the study period.
  • 7.Subjects willing to refrain from any type of hair treatment like perming, straightening etc.
  • during the study duration 8.Subjects who agree not to change their regular regimen (including hair oils).
Exclusion Criteria
  • 1.Subjects who have undergone hair growth treatment within 3 months before screening into the study.
  • 2.Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
  • 3.Subjects (male) having androgenic alopecia, male pattern baldness’ not be included in study.
  • 4.Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
  • 5.Subjects (females) who are pregnant or lactating 6.Subjects who have had hair transplant.
  • 7.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
  • 8.Chronic illness which may influence the cutaneous state.
  • 9.Subjects participating in other similar cosmetic or therapeutic trial within last three months 10.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
  • 11.Subjects (males) who are having androgenic alopecia, male pattern baldness.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Significant improvement in dandruff condition by expert/dermatologist assessment4 weeks product and 2 weeks regression
Secondary Outcome Measures
NameTimeMethod
Significant reduction and prevention of dandruff associated conditions by expert/dermatologist assessment4 weeks product and 2 weeks regression

Trial Locations

Locations (1)

MS Clinical Research Pvt. Ltd.

🇮🇳

Bangalore, KARNATAKA, India

MS Clinical Research Pvt. Ltd.
🇮🇳Bangalore, KARNATAKA, India
Dr Vidya Kuntoji
Principal investigator
08041125934
vidya@mscr.in

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