A study to evaluate the Safety and Efficacy of Anti-Dandruff Shampoo (HADM-022202).
- Registration Number
- CTRI/2022/09/045222
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 113
1) Subjects with dandruff determined by ASFS score 24 to 34 with itching and flaking.
2) Subjects with visible flakes.
3) Subjects with different hair types [normal, oily, dry, colored (synthetic and henna colored) and permed hair].
4) Subjects willing to refrain from using other products on the scalp other than those provided, including other shampoos/conditioners, scalp and hair treatment and oils/ products that has anti-dandruff action during the study period.
1) History of any dermatological conditions of the scalp (other than dandruff or seborrheic dermatitis) that would interfere with the diagnosis or assessment (e.g. psoriasis, eczema, atopic dermatitis, or other skin/scalp infections).
2) Subjects with excessive erythema, crusting or a significant number of pustules/papules on the scalp.
3) History of skin cancer or treatment for any type of cancer within the last 2 years.
4) History of prior use of antidandruff treatment on scalp within past 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Effect of test product on reduction in adherent scalp flaking score (ASFS) <br/ ><br> <br/ ><br>2) Effect of test product in reduction in visible dandruff flakes through dandruff Strip test methodTimepoint: Day 01 (before application) and Day 28 (± 2 days)
- Secondary Outcome Measures
Name Time Method Effect of test product on reduction in itching evaluated through VAS (0-10) scoreTimepoint: Day 01 before application to Day 28 (± 2 days);Evaluation for reduction in dandruff, healthy and clean scalp with a burst of freshness and cooling sensation through subjective questionnaireTimepoint: Day 28 (± 2 days);To assess the suitability of test product / subject response index [consumer perception about product] for all hair typesTimepoint: Day 28 (± 2 days)