Assessment of safety and effectiveness of Plant Based Biotin in Healthy Human Subjects with thin, dry, and brittle hair.

Not Applicable

Completed

• Registration Number: CTRI/2022/10/046324
• Lead Sponsor: Zywie Ventures Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-11
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 51

Inclusion Criteria

1)Age: 30 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 self-proclaimed nonpathological thin, dry and brittle hair.

6)Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).

7)Subject has a score of at least â??mild skin agingâ?? based on PGA at screening visit.

8)Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.

9)Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.

10)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.

11)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.

12)Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.

13)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.

14)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.

15)Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.

16)Subjects are willing to give written informed consent and are willing to follow the study procedure.

17)Subjects who have used other marketed products for hair thinning in the past.

18)Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study.

19)Willing to use test product throughout the study period

Exclusion Criteria

Subjects must not be enrolled in the study if they meet any one of the following criteria:

1)Subjects with a history of hair thinning/hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc.

2)Subject has a history of allergy or sensitivity to the test treatment ingredients like sesbania agati and others etc.

3)Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).

4)Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.

5)Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.

6)Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.

7)Subject is currently pregnant/breastfeeding.

8)Subject has a history of prior use of hair growth treatment within 3 months.

9)Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).

10)Subject has a history of alcohol or drug addiction.

11)Subjects who have plans of shaving scalp hair during the study.

12)Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.

13)Subject who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight.

14)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion.

15)Pregnant or breastfeeding or planning to become pregnant during the study period.

16)History of chronic illness which may influence the cutaneous state.

17)Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp/skin care products within the last four weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of the test treatment in terms of change in hair density, thickness and scalp condition, reduction in the facial wrinkle and fine lines of Crowâ??s feet areaTimepoint: from baseline before test treatment usage to day <br/ ><br>28 and day 56 post test treatment usage