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Clinical Study on the Safety and Effectiveness of an Anti-Dandruff Shampoo on healthy human subjects.

An Open-Label, Single-Arm, Clinical Safety, Efficacy and In-Use Tolerability Study of KORE Anti-Dandruff Shampoo to Evaluate Reduction in Flaking, Itching and Redness in Healthy Human Subject with Mild to Moderate Dandruff on Scalp. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098412
Enrollment
20
Registered
2025-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

None listed

Interventions

Intervention1: KORE Anti-Dandruff Shampoo: Mode of Usage: Apply a sufficient amount of the shampoo onto wet scalp and hair. Gently massage the scalp for 2 3 minutes, ensuring even distribution. Leave

Sponsors

OG Beauty Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age: 20-50 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females). 3) Females of childbearing potential must have a self-reported negative urine pregnancy. 4) Subject is in good general health as determined by the Investigator on the basis of medical history. 5) Subjects have unwashed and untreated scalp for 2 days. 6) Subject exhibiting mild to moderate dandruff status as per ASFS at screening. 7) Subjects are willing to give written informed consent and are willing to follow the study procedure. 8) Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-dandruff agents) or any other hair growth, hair fall treatment, or hair products other than the test product for the entire duration of the study. 9) Willing to use test product throughout the study period.

Exclusion criteria

Exclusion criteria: 1) History of any dermatological condition of the scalp other than hair loss and/or dandruff. 2) History of alcohol or drug addiction. 3) Subjects using other marketed dandruff control and/or hair growth products during the study period. 4) Subjects who have plans of shaving scalp hair during the study. 5) Subjects who are on chronic oral steroids 03 months before initial application and during the study period. 6) History or present condition of irritated or visibly inflamed scalp or severe scalp disease. 7) Subjects having a history or present condition of an allergic response to any cosmetic products. 8) Any other condition which could warrant exclusion from the study, as per the dermatologist s/investigator s discretion. 9) Pregnant or breastfeeding or planning to become pregnant during the study period. 10) History of chronic illness which may influence the cutaneous state. 11) Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of the test product by change in: 1. Adherent Flakes 2. Non-Adherent Flakes 3. Scalp Itchiness 4. ErythemaTimepoint: From baseline on Day 01 and post-usage of test product on Day 01, Day 07 (+2 Days), Day 15 (+2 Days).

Secondary

MeasureTime frame
To evaluate the effectiveness of the test product by assessing change in scalp barrier function from baseline before and post usage of test product.Timepoint: From baseline on Day 01 and post-usage of test product on Day 01, Day 07, Day 15.;To evaluate the effectiveness of the test product by assessing change in scalp hydration from baseline before and post usage of test product.Timepoint: From baseline on Day 01 and post-usage of test product on Day 01, Day 07, Day 15.;To evaluate the effectiveness of the test product by assessing reduction in hair fall from baseline before and post usage of test product.Timepoint: From baseline on Day 01 and post-usage of test product on Day 01, Day 07, Day 15.;To evaluate the effectiveness of the test product by assessing change in general appearance of scalp from baseline before and post usage of test product.Timepoint: From baseline on Day 01 and post-usage of test product on Day 01, Day 07, Day 15.;To evaluate the effectiveness of the test product by assessing product perception questionnaire through 5-point Likert scale baseline before and after usage of test product.Timepoint: From baseline on Day 01 and post-usage of test product on Day 01, Day 07, Day 15.

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Pvt Ltd.

dr.nayan@novobliss.in9909013286

Outcome results

None listed

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