A Clinical Study to Assess Safety, Efficacy and In-use Tolerability of Different Dosages of Hair … (NCT06551818) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess Safety, Efficacy and In-use Tolerability of Different Dosages of Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III).
India72 participantsStarted 2024-09-23
Plain-language summary
This is a prospective, interventional, exploratory, four-arm - dose response study, comparative, double-blind, randomized, placebo-control, proof of concept, safety, efficacy and in-use tolerability study of three different dosage formulation of test hair growth products and placebo in patients with mild to moderate Androgenic Alopecia (Grade I to III).
Who can participate
Age range
25 Years – 45 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: 25 to 45 years and above (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.
. Patient is in good general health as determined by the Investigator on the basis of medical history.
. Patients having mild to moderate Androgenic Alopecia (Grade I to III) during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification and Ludwig pattern scale for female.
. Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
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 in hair thickness by using CASLite Nova (instrumental analysis)
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
2
Change in hair density by using CASLite Nova (instrumental analysis)
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
3
Change in hair growth rate by using CASLite Nova (instrumental analysis)
Timeframe: 04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180
. Patient 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 patient 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.
Exclusion criteria
. Patient have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
. Patient have history of any dermatological condition of the scalp other than hair loss and dandruff.
. Patient have history of any prior hair growth procedures (e.g. hair transplant or laser).
. Patient who had taken topical treatment of hair loss for at least 4 weeks.
. Patient who had taken any systemic treatment for at least 3 months.
. History of alcohol or drug addiction.
. Patient having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
. Patient who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight.