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Completed NCT07195487

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.

Conditions: Thinning Hair

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 34
Sponsor: NovoBliss Research Pvt Ltd

Location: NovoBliss Research Private Limited Ahmedabad Gujarat

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 Growth and Scalp Health Serum.

Eligibility Criteria

Inclusion Criteria: 1. Age: 18-55years (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 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 6. 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. 7. 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. 8. Subjects are willing to give written informed consent and are willing to follow the study procedure. 9. 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. 10. Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments. 11. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 12. 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 self-reported problems like anaemia, thyroid problems. 2. Subject have history of any prior hair growth procedures done (e.g. hair transplant or laser). 3. Subject who had taken topical product of hair loss for at least 4 weeks before enrolment. 4. Subject who had taken any systemic product for any illnesses for at least 3 months. 5. History of alcohol or drug addiction. 6. Subject having history or resent condition of severely irritated or visibly inflamed scalp or severe scalp disease. 7. Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study. 8. Pregnant or breast feeding or planning to become pregnant during the study period. 9. History of chronic illness which may influence the cutaneous state. 10. Subject have participated any clinical research study related to hair care products. 11. 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. 12. 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07195487). StuddyBuddy aggregates publicly available trial information.