Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
NovoBliss Research Pvt Ltd
Collaborating Sponsors:
Blossom Microbiotics LLC
Conditions:
Thinning Hair
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 Gr...
Detailed Description
A total of 34 participants, including males and non- pregnant, non-lactating females aged between 18 and 55years (inclusive) with Mild to Moderate Hair Thinning will be enrolled in the study. The stud...
Eligibility Criteria
Inclusion
- 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.
- Subjects 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.
- Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
- Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- Subject must be able to understand and provide written informed consent to participate in the study.
Exclusion
- Subject have history of severe hair fall due to any clinically significant self-reported problems like anaemia, thyroid problems.
- 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.
- History of chronic illness which may influence the cutaneous state.
- Subject have participated any clinical research study related to hair care products.
- Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or product of any type of cancer within the last 6 months.
- Participants with advanced baldness (Norwood 4-7, Ludwig 3), long-standing bald patches (\>1 year), scarring alopecia, active scalp infections, recent use of hair growth treatments (e.g., minoxidil or finasteride within the past 3 months), severe scalp conditions, or known allergies to any test product ingredients will be excluded.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 25 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT07195487
Start Date
October 1 2025
End Date
January 25 2026
Last Update
September 26 2025
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