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 range18 Years – 55 Years
SexALL
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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.
✓. 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.
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).
✕. 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.