None listed
Conditions
Interventions
Intervention1: 2.5% Formulation: Mode of Usage: Apply the test product once daily in the evening for 120 days
Route of Administration: Topical
Intervention2: 5% Formulation: Mode of Usage: Apply the
Sponsors
Keva – S H Kelkar and Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 20 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 partially gray hair. 6) Subject with low hair growth and complaint of hair fall. 7) Subject with self-assessed complaint of thinning of hair. 8) 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. 9) 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. 10) 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. 11) Subjects are willing to give written informed consent and are willing to follow the study procedure. 12) 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. 13) Willing to use test product throughout the study period.
Exclusion criteria
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of the test products in terms of change in hair growth rate and A:T ratio. 2. To evaluate the effectiveness of the test products in terms of change in hair density, hair thickness. 3. To evaluate the effectiveness of the test products in terms of change in hair fall. 4. To evaluate the effectiveness of the test product in terms of change in graying severity score (GSS). Timepoint: From baseline on day 01 before test products usage and on day 30 (±2 days), day 60 (±2 days), day 90 (±2 days) and day 120 (±2 days) post products usage | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of the test products in terms of change in hair strength.Timepoint: From baseline on day 01 before test products usage and on day 30 (±2 days), day 60 (±2 days), day 90 (±2 days) and day 120 (±2 days) post products usage ;2. To evaluate the effect of the test products in terms of scalp skin appearance i.e. itchiness, redness, roughness, and scaliness of scalp.Timepoint: From baseline on day 01 before test products usage and on day 30 (±2 days), day 60 (±2 days), day 90 (±2 days) and day 120 (±2 days) post products usage. ;3. To evaluate the consumer perception about product using subjective questionnaire.Timepoint: From baseline on day 01 before test products usage and on day 30 (±2 days), day 60 (±2 days), day 90 (±2 days) and day 120 (±2 days) post products usage. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed