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To check the Safety and Effectiveness of Hair Fall Control Shampoo in Healthy Adult Human Subjects with Hair Fall Complaints

A Proof-Of-Concept, Safety and Efficacy Study of Hair Fall Control Shampoo in Healthy Adult Human Subjects with Hair Fall Complaints

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044868
Enrollment
32
Registered
2022-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

None listed

Interventions

Intervention1: Trichup - Hair Fall Control Shampoo: Apply Hair Fall Control Shampoo twice a week on the scalp and hair strands, massage the scalp using fingers, leave for 1-2 minutes and rinse thoroug

Sponsors

Vasu Healthcare Private Limited Vasu Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age: 18 to 45 years (both inclusive) at the time of consent. 2) Sex:  Healthy males and non-pregnant/non-lactating females. 3) Females of childbearing potential must have a self-reported negative pregnancy test. 4)Subjects are generally in good health. 5) Females with 50-60 counts and males with 30-40 counts of hair fall from the hair combing method (60-sec hair count) at the screening visit 1 before product application. 6)Subjects have unwashed and untreated scalp for 5 days. 7) All hair colours except grey hair. 8) Subjects with self-proclaimed nonpathological thinning of hair.   9) Subjects are willing to give written informed consent and are willing to follow the study procedure. 10)Subjects who have used other marketed products for hair fall control in past. 11) Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair growth, hair fall treatment, or hair products other than the test product for the entire duration of the study. 12) Willing to use test product throughout the study period.

Exclusion criteria

Exclusion criteria: 1)Subjects with a history of severe hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc. 2) History of any dermatological condition of the scalp other than hair loss and/or dandruff. 3) History of prior use of hair fall control | hair growth treatment within 3 months. 4)History of any prior hair growth procedures (e.g., hair transplant or laser). 5) Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study. 6)History of alcohol or drug addiction. 7)Subjects using other marketed hair fall control and/or hair growth products during the study period. 8)Subjects who have plans of shaving scalp hair during the study. 9)Subjects who are on chronic oral steroids 03 months before initial application and during the study period. 10)History or present condition of irritated or visibly inflamed scalp or severe scalp disease. 11)Subjects having a history or present condition of an allergic response to any cosmetic products. 12)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion. 13)Pregnant or breastfeeding or planning to become pregnant during the study period. 14)History of chronic illness which may influence the cutaneous state. 15)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
Mean percentage change in hair fall reduction using 60-S Hair count techniqueTimepoint: Day 01 before application to 1st Wash on Day 01, 15 and 30 post-usage of a test product

Secondary

MeasureTime frame
Safety of hair and scalp will be determined by treatment-emergent adverse events such as erythema, oedema, pain, pruritus, and urticarial assessed by the DermatologistTimepoint: Throughout the Study Duration;To assess the effect of the test product in terms of change in the general appearance of hair i.e. hair volume, hair reflection, hair plasticity, hair density, hair smoothness, hair oiliness, hair shininess after 30 Days of usageTimepoint: Day 01 before application to 1st Wash on Day 01, 15 and 30 post-usage of a test product;To assess the effect of the test product in terms of hair strength (i.e., poor, average, good) post-usage of 30 DaysTimepoint: Day 01 before application, on Day 15 and Day 30 post-usage;To assess the effect of the test product in terms of product perception after 30 Days (4 weeks) of usageTimepoint: Day 01 before application, on Day 7, Day 15, Day 21 and Day 30 post-usage;To assess the effect of the test product in terms of Scalp Appearance i.e. itchiness, redness, roughness, and scaliness of scalp after 30 Days of usageTimepoint: Day 01 before application, on Day 15 and Day 30 post-usage;To assess the effect of the test product in terms of Scalp Hydration post-usage of test product using MoistureMeterEpidDTimepoint: Day 01 before application to 1st Wash on Day 01, 15 and 30 post-usage of a test product

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in91-9909013286

Outcome results

None listed

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