A clinical study to assess the safety and effectiveness of Anti-Gray Hair Product in Healthy Adult Human Subjects with Partially Gray Hair
- Registration Number
- CTRI/2023/01/048861
- Lead Sponsor
- Anveya Living Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
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.
11)Willing to use test product throughout the study period.
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.
11)Subjects having a history or present condition of an allergic response to any cosmetic products.
12)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion.
13)Pregnant or breastfeeding or planning to become pregnant during the study period.
14)History of chronic illness which may influence the cutaneous state.
15)Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the effectiveness of test product in terms of improvement in anti-graying of the hair after test product usage using pictures taken from CASLite Nova and Image-pro software analysis <br/ ><br>2. 2.To assess the effectiveness of the test product in terms of improvement in hair growth and morphology of the hair using pluck test. <br/ ><br>3.To assess the effectiveness of the test product in terms of change in Graying severity score (GSS) <br/ ><br>Timepoint: 1. On Day 30, Day 60, Day 90, Day 120 from baseline <br/ ><br>2. On day 120 from baseline <br/ ><br>3. On Day 30, Day 60, Day 90, Day 120 from baseline
- Secondary Outcome Measures
Name Time Method 1.To assess the effect of the test product in terms of change in the general appearance of hair as evaluated by the Dermatologist Trained Evaluator | DermatologistTimepoint: On Day 30, Day 60, Day 90, Day 120 from baseline;2.To assess the effect of the test product in terms of Scalp Appearance as evaluated by the Dermatologist Trained Evaluator | DermatologistTimepoint: On Day 30, Day 60, Day 90, Day 120 from baseline;3.To assess the effect of the test product in terms of hair strength using pull testTimepoint: On Day 30, Day 60, Day 90, Day 120 from baseline;4.To assess the effect of the test product in terms of product perception using the subjective perception questionnaires about the product.Timepoint: On Day 30, Day 60, Day 90, Day 120 from baseline