Status:
NOT_YET_RECRUITING
Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy Real World Evidence Study.
Lead Sponsor:
NovoBliss Research Pvt Ltd
Conditions:
Hair Fall and Pre-mature Graying
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This is proof-of-science, prospective, interventional, three-arm, double-blind, randomized, safety and efficacy real world evidence study of herbal and non herbal formulations in healthy human subject...
Detailed Description
Considering the clinical safety, efficacy study a sufficient number 99 subjects (33 subject/arm) will be enrolled to 90 subjects (30 subject/arm) completed the study. In each arm, fifteen (15) partici...
Eligibility Criteria
Inclusion
- Age: 18 to 55 years and above (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.
- Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
- Subject having AGA and premature Gray hair at a time of screening.
- Subject having premature gray hair at a time of screening.
- Subject with pro-claimed nonpathological thinning of hair.
- 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 beconsidered 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 (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
- Willing to use test products throughout the study period.
- Subject is willing and able to follow and allow study staff to performed study test methods.
- 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 problems like anaemia, thyroid problems.
- Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
- Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
- Subject who had taken topical treatment of hair loss for at least 4 weeks.
- Subject who had taken any systemic treatment for at least 3 months.
- History of alcohol or drug addiction.
- Subject having history or resent condition of 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 treatment of any type of cancer within the last 6 months.
Key Trial Info
Start Date :
August 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06552039
Start Date
August 24 2024
End Date
December 24 2024
Last Update
August 13 2024
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