A Clinical Study to Evaluate the Safety, Effectiveness and In-Use Tolerability of Hair Growth and… (NCT07195487) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Clinical Study to Evaluate the Safety, Effectiveness and In-Use Tolerability of Hair Growth and Scalp Health Serum in Subjects With Mild to Moderate Hair Thinning.
India34 participantsStarted 2025-11-18
Plain-language summary
This is a Prospective, Interventional, Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Clinical Study to Evaluate the Safety, Efficacy and In-Use Tolerability of Fermented Extract Hair Growth and Scalp Health Serum.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18-55years (both inclusive) at the time of consent.
. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
. Females of childbearing potential must have a self-reported negative urine pregnancy.
. Subject is in good general health as determined by the Investigator on the basis of medical history.
. Patients must have a confirmed diagnosis of mild to moderate hair thinning, during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification for male (Grade 1-3) and Ludwig pattern scale for female (Grade 1-2) with active hair shredding
. Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Hair Growth Rate measured by CASLiteNova from the tattoo-marked area
Timeframe: Baseline (Day -4 to Day 1, prior to treatment), Day 42 (±2 days), Day 45 (±2 days), Day 87 (±2 days), and Day 90 (±2 days).
2
Change from Baseline in Baby Hair Count and Hair Length measured by CASLiteNova from the bald scalp area
Timeframe: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).)
3
Change from Baseline in Hair Density and Hair Thickness measured by CASLiteNova
Timeframe: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).
. If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
. Subjects are willing to give written informed consent and are willing to follow the study procedure.
Exclusion criteria
. Subject have history of severe hair fall due to any clinically significant self-reported problems like anaemia, thyroid problems.
. Subject have history of any prior hair growth procedures done (e.g. hair transplant or laser).
. Subject who had taken topical product of hair loss for at least 4 weeks before enrolment.
. Subject who had taken any systemic product for any illnesses for at least 3 months.
. History of alcohol or drug addiction.
. Subject having history or resent condition of severely irritated or visibly inflamed scalp or severe scalp disease.
. Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
. Pregnant or breast feeding or planning to become pregnant during the study period.