A Study to Assess the Safety and Effectiveness of a Hair Growth Serum in People with Mild to Moderate Androgenic Alopecia (Grades I–III).

Not yet recruiting

• Conditions: Androgenic alopecia, unspecified,

• Registration Number: CTRI/2025/05/086158
• Lead Sponsor: OneSto Labs Private Ltd.

Brief Summary

This is a prospective, single- arm, single- centre, open -label, clinical safety and efficacy study of hair growth serum in the patients with mild to moderate AGA (Grade I-III)

A total of 32 subjects with an age of 18-55 years of age will be enrolled to complete 30 subjects of the study.

subjects will be instructed to visit the facility as per below visit:

Visit 01 (Day 01): Screening, Enrolment, baseline evaluation

Visit 02 (Day 40): Treatment usage period, and Evaluation Visit

Visit 03 (Day 80):Treatment Usage Period and Evaluation Visit

Visit 04 (Day 120): Evaluation and End of Study

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-30
• Study Start: 2025-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 1)Age: 18-55 years (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.
• 10)Patients who commit not to use any other medicated/ prescription shampoos/hair care products, any other hair growth products or hair colour or dye, other than the test treatment for the entire duration of the study.
• 11)Willing to use test treatment throughout the study period.
• 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.
• 12)Subjects 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. hair growth (in terms of hair length)	Day 01, Day 40, Day 80 and Day 120
2. hair thickness and hair density	Day 01, Day 40, Day 80 and Day 120
To evaluate the effectiveness of the test treatment in terms of change in	Day 01, Day 40, Day 80 and Day 120

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of the test treatment in terms of change in	1. Change in A: T

Trial Locations

Locations (1)

NovoBliss Research Private Limited; 🇮🇳 Ahmadabad, GUJARAT, India

NovoBliss Research Private Limited

🇮🇳Ahmadabad, GUJARAT, India

Dr Nayan Patel

Principal investigator

09909013286

dr.nayan@novobliss.in