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A clinical study of test products in healthy adult human male subjects having patchy beards and scalp hair fall complaints.

A Clinical Study on the Safety, Efficacy, and In-Use Tolerability of Beard and Scalp Hair Growth Oils in Healthy Adult Males having patchy beards and scalp hair fall complaints - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081166
Enrollment
75
Registered
2025-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

None listed

Interventions

Intervention1: Oil with Herbal Active: Dose: 5-6 drops of oil Dosage Form: Liquid Mode of Usage: Take 5-6 drops of oil in the palm and rub it across the patch beard and hair scalp and gently massage

Sponsors

Marico Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age includes males having age of 21 to 30 years at the time of consent. 2) Subject are generally in good health. 3) Subjects with daily hair fall exceeding 100 strands/day and more than 25 strands falling during a 60-second hair combing test at the time of screening on Day -04. 4) Subject with patchy beards. 5) Subjects having normal dihydrotestosterone and free testosterone hormone levels during screening testing. 6) Subjects are willing to give written informed consent and are willing to follow the study procedure. 7) Subjects who commit not to use medicated/ prescription shampoos/hair care and beard related products (containing Minoxidil), any other hair or beard growth products or hair or beard colour or dye, other than the test products for the entire duration of the study. 8) Willing to use test product throughout the study period.

Exclusion criteria

Exclusion criteria: 1) History of any dermatological condition of the scalp (hair scalp and beard skin) other than hair loss. 2) History of prior use of hair growth or beard treatment within 3 months. 3) History of any prior hair growth or beard procedures ( hair transplant or laser). 4) Subjects who have applied topical treatment for hair or beard loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study. 5) Subject who perform any salon treatment on hair including haircut beard cutting during the study period. 6) History of alcohol or drug addiction. 7) Subjects using other marketed hair fall control and/or hair or beard growth products during the study period. 8) Subjects who have plans of shaving scalp and beard 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 dermatologist s/investigator s discretion. 13) History of chronic illness which may influence the cutaneous state. 14) 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 products in terms of change in. 1. hair growth rate 2. hair density, hair thickness 3. patchy beard 4. number of hair follicles 5. hair shine Timepoint: 1. From baseline visit i.e., during Visit 01 (04 days before (Day 01) and Visit 02 (Day 01) before application and after products usage on Visit 03 (Day 18), Visit 04 (Day 21), Visit 05 (Day 42), Visit 06 (Day 45) and on Visit 07 (Day 87), Visit 08 (Day 90). From baseline before test products usage on Day 01, and after test products usage on Day 21, Day 45, and Day 90.

Secondary

MeasureTime frame
To evaluate the absorption of the test products by the tissue absorbent test.Timepoint: after usage of the test products at T20 mins On Day 01;To evaluate the effectiveness of the test products in terms of change in general appearance of the hair and scalpTimepoint: From baseline before test products usage on Day 01, and after test products usage on Day 21, Day 45, and Day 90;To assess the effectiveness of the test products in terms of change in hair fall reduction.Timepoint: From baseline before test products usage on -04 before Day 01, and after test products usage on Day 21, Day 45, and Day 90;To assess the effect of the test products in terms of products perceptionTimepoint: From baseline before test products usage on Day 01, and after usage of the test products on Day 21, Day 45, and Day 90.

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in9909013286

Outcome results

None listed

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