A clinical study to assess the safety and effectiveness of test products in healthy adult human subjects having hair fall complaints.
- Conditions
- Health Condition 1: L639- Alopecia areata, unspecified
- Registration Number
- CTRI/2024/07/070860
- Lead Sponsor
- Soulflower – PT INVENT INDIA PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Age: 18 to 55 years (both inclusive) at the time of consent.
2) Sex: Healthy 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 more than 100 hair fall per day.
6) Subject with self-assessed complaint of thinning of hair.
7) 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.
8) 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.
9) 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.
10) Subjects are willing to give written informed consent and are willing to follow the study
procedure.
11) Subjects who commit not to use medicated/ prescription shampoos/hair care products
(containing Minoxidil), any other hair growth hair products or hair colour or dye, other than
the test products for the entire duration of the study.
12) Willing to use test product throughout the study period
1) History of any dermatological condition of the scalp other than hair loss.
2) History of prior use of hair growth treatment within 3 months.
3) History of any prior hair growth procedures (e.g., hair transplant or laser).
4) 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.
5) Subject who perform any salon treatment on hair including haircut during the study period.
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
dermatologist’s/investigator’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
- Secondary Outcome Measures
Name Time Method