CTRI/2024/08/071885Not yet recruitingUnknown
Exploratory, prospective, three-arm, interventional, comparative, randomized, double-blind, placebo-controlled, safety, efficacy and in-use tolerability study of hair growth product(s) in patients with mild to moderate androgenic alopecia. (Grade I to III). - NI
Zywie Ventures Privated Ltd0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1) Age: 25 to 45 years and above (both inclusive) at the time of consent.
- •2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males
- •and females).
- •3) Females of childbearing potential must have a self-reported negative urine pregnancy.
- •4) Subject is in good general health as determined by the Investigator on the basis of medical
- •5) 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.
- •6) Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
- •7) 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.
- •8) 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.
- •9) Patients are willing to give written informed consent and are willing to follow the study
- •10) Patients who commit not to use any other medicated/ prescription shampoos/hair care
- •products (containing Minoxidil), any other hair growth products or hair colour or dye,
- •other than the test products for the entire duration of the study.
- •11) Willing to use test products throughout the study period.
- •12) Subject is willing and able to follow and allow study staff to performed study test methods.
- •13) Subject is willing and able to follow the study directions, to participate in the study,
- •returning for all specified visits.
- •14) Subject must be able to understand and provide written informed consent to participate
- •in the study.
Exclusion Criteria
- •1) Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
- •2) Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
- •3) Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
- •4) Subject who had taken topical treatment of hair loss for at least 4 weeks.
- •5) Subject who had taken any systemic treatment for at least 3 months.
- •6) History of alcohol or drug addiction.
- •7) Subject having history or resent condition of irritated or visibly inflamed scalp or severe
- •scalp disease.
- •8) Subject having history or present condition of an allergic response to any cosmetic
- •products, any other condition which could warrant exclusion from the study.
- •9) Pregnant or breast feeding or planning to become pregnant during the study period.
- •10) History of chronic illness which may influence the cutaneous state.
- •11) Subject have participated any clinical research study related to hair care products.
- •12) Subject have history of mastectomy for cancer involving removal of lymph nodes within
- •the past year, or treatment of any type of cancer within the last 6 months.
Investigators
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