None listed
Conditions
Interventions
Intervention1: Test Product - Shampoo: Quantity - As per consumer habit/requirement followed at home.
Method of Use - Application on the scalp
Frequency - 3 times a week
Duration - 6 weeks
Interventio
Sponsors
Hindustan Unilever Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects in general good health. Subjects in the age group 18-45 years (both the ages inclusive). Subjects willing to give a written informed consent and agree to come for a regular follow up visit. Subjects with moderate to severe level of dandruff (score of >36 Sum of all sections (B. Adherent dandruff) + Sum of all sections (A. Dandruff Occurrence level) Subjects willing to abide by and comply with the study protocol. Subjects who have not participated in a similar investigation in the past three months. Subjects who agree to refrain from using hair dye / hair colour during the study period. Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration
Exclusion criteria
Exclusion criteria: Subjects who have undergone hair growth treatment within 3 months before screening into the study. Subjects having any active scalp disease which may interfere in the study â?? dermatologistâ??s judgement. Subjects (male) having androgenic alopecia, male pattern baldnessâ?? not be included in study. 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. Subjects (females) who are pregnant or lactating Subjects who have had hair transplant. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. Chronic illness which may influence the cutaneous state. Subjects participating in other similar cosmetic or therapeutic trial within last three months Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, serious disorder of heart and respiratory apparatus or any other serious medical illness. Subjects (males) who are having androgenic alopecia, male pattern baldness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the efficacy of Test product in reduction of dandruff over Treatment Phase and Regression Phase in comparison to baseline. To study the efficacy of Test product in reduction of dandruff over Treatment Phase and Regression Phase in comparison to placebo and control product.Timepoint: 1.Significant reduction in dandruff occurrence level post application of the Test products at week 1, 2, 3 and4, in comparison to baseline. 2.Significant reduction in severity of dandruff flakes score at week 1, 2, 3 and 4 in comparison to baseline. 3.Significant reduction in total dandruff score at week 1, 2, 3 and 4in comparison to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To study the efficacy of Test product in reduction of dandruff at week 1, week 2, week 3, week 4, in comparison to baseline. â?¢ To study the efficacy of Test product in reduction of dandruff at week 1, week 2, week 3, week 4, in comparison to placebo and benchmark product â?¢ Comparison of Anti dandruff efficacy after regression phase i.e. week 6. ï?? Week 6 vs week 4 ï?? Week 6 vs baseline â?¢ To evaluate the product acceptance& tolerance.Timepoint: 1.Significant reduction in adherent dandruff at week 1, 2, 3 and 4in comparison to baseline for each Test product. 2.Significant reduction in non-adherent dandruff at week 1, 2, 3and 4in comparison to baseline for each Test product. 3.Reduction in itching at week 1, 2, 3 and 4 in comparison to baseline. | — |
Countries
India
Contacts
Public ContactDr Subrahmanya P
Alvas Ayurveda Medical College
Outcome results
None listed