CTRI/2023/01/048861
Completed
未知
A Proof-of-Concept, Safety, and Efficacy Study of Anti-Gray Hair Product in Healthy Adult Human Subjects with Partially Gray Hair
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Anveya Living Private Limited
- Enrollment
- 84
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Age: 20 to 55 years (both inclusive) at the time of consent.
- •2\)Sex: Healthy males and non\-pregnant/non\-lactating females.
- •3\)Females of childbearing potential must have a self\-reported negative pregnancy test.
- •4\)Subject are generally in good health.
- •5\)Subject with partially gray hair.
- •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\)If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- •9\)Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •10\)Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil) or any other hair growth, or hair products other than the test product for the entire duration of the study.
Exclusion Criteria
- •1\)Subjects with any other hair colour except gray.
- •2\)History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3\)History of prior use of hair growth treatment within 3 months.
- •4\)History of any prior hair growth procedures (e.g., hair transplant or laser).
- •5\)Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •6\)History of alcohol or drug addiction.
- •7\)Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •8\)Subjects who have plans of shaving scalp hair during the study.
- •9\)Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •10\)History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
Outcomes
Primary Outcomes
Not specified
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