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Anti-Dandruff Shampoo Testing on healthy male and females adult subjects.

An Open Label, Single-Arm, Multicentre, Clinical Study to Evaluate Efficacy and Safety of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruff.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034226
Enrollment
110
Registered
2021-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Cliantha Code A: Anti Dandruff Shampoo HADR-111801S: Anti Dandruff Shampoo: Sufficient Quantity (depending upon length of hair)
Duration of Therapy: 28 days Control Intervention1: NA: NA

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 60 years (both inclusive) at the time of consent. 2. Sex: Healthy male or non-pregnant/non-lactating female. 3. Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening visit and Enrolment. 4. Subjects generally in good health and willing to give written informed consent and willing to follow study procedure. 5. Subjects with dandruff determined by ASFS score 24 to 48 with itching and flaking. 6. Subjects with visible flakes. 7. 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. 8. Subjects completing the conditioning phase. 9. Subjects willing to use test product throughout the study period. 10. Subjects must be able to understand and provide written informed consent to participate in the study. 11. Subjects should be willing and able to follow the study protocol to participate in the study.

Exclusion criteria

Exclusion criteria: 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. 5) Participation in a similar clinical study within the previous 90 Days. 6) Subjects with a history or present condition of an allergic response to dandruff shampoos or any cosmetic products or component present in the test product. 7) Any other condition which could warrant exclusion from the study, as per the Dermatologistââ?¬•s/investigatorââ?¬•s discretion.

Design outcomes

Primary

MeasureTime frame
The objective of this study is to evaluate the safety and efficacy of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruffTimepoint: Day 01, Day 07, Day 15, Day 28, Day 30, Day 31 and Day 32

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026