An exploratory clinical study to assess Safety, Efficacy and In-Use tolerability of three different hair growth products in patients with mild to moderate androgenic alopecia (Grade I to III).
- Conditions
- Health Condition 1: L649- Androgenic alopecia, unspecified
- Registration Number
- CTRI/2024/08/071885
- Lead Sponsor
- Zywie Ventures Privated Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
history.
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
procedure.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the effectiveness of the test products in terms of change in hair thickness, and hair density by using CASLite Nova <br/ ><br>2.To assess the effectiveness of the test products in terms of change in hair growth rate by using CASLite Nova <br/ ><br>Timepoint: 1. 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 <br/ ><br>2. 04 days before Day 01, Day 01, Day 87, Day 90 and on Day 177, on Day 180
- Secondary Outcome Measures
Name Time Method