A Clinical Study to Assess Safety, Efficacy and In-use Tolerability of Different Dosages of Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III).

Launched by NOVOBLISS RESEARCH PVT LTD · Aug 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of different dosages of hair growth products for people experiencing mild to moderate hair loss, known as androgenic alopecia. The study will compare three different formulations of these products against a placebo, which is an inactive treatment, to see how well they work and how well people tolerate them. It is designed for adults aged 25 to 45, both men and women, who have been experiencing hair loss at specific levels.

To participate, individuals must be in good health and not currently using other hair treatments. They should also be able to commit to following the study guidelines and attending all required visits. Participants will use the test products for the duration of the study and will be monitored for their hair growth progress and any side effects. It’s important to note that the study is not yet recruiting participants, but it aims to help improve treatments for hair loss in the future.

Gender

ALL

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. Patient 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. Patient 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 patient 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 consume test products throughout the study period.
• • 12. Patient is willing and able to follow and allow study staff to performed study test methods.
• • 13. Patient is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• • 14. Patient must be able to understand and provide written informed consent to participate in the study.
• Exclusion Criteria:
• • 1. Patient have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
• • 2. Patient have history of any dermatological condition of the scalp other than hair loss and dandruff.
• • 3. Patient have history of any prior hair growth procedures (e.g. hair transplant or laser).
• • 4. Patient who had taken topical treatment of hair loss for at least 4 weeks.
• • 5. Patient who had taken any systemic treatment for at least 3 months.
• • 6. History of alcohol or drug addiction.
• • 7. Patient having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
• • 8. Patient who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight.
• • 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. Patient have participated any clinical research study related to hair care products.
• • 12. Patient 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.