None listed
Conditions
Interventions
Intervention1: Utixira Lotion
: Mode of Usage: To be applied over the affected areas twice a day as a thin film and rubbed in gently and completely.
Duration: 30 days
Frequency: Twice a Day
Route of
Sponsors
SAVA Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 55 years (both inclusive) at the time of consent. 2) Sex: Healthy male 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 dry or sensitive skin at a time of screening. (Dermatological Assessment) 6) Subjects having pruritus or urticaria at a time of screening. 7) Subjects assessment site must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds. 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) Subjects are willing to give written informed consent and are willing to come for regular follow up. 11) Subjects who commit not to use medicated skincare product other than the test product for the entire duration of the study. 12) Subject who have not participated in a similar investigation in the past three months. 13) Willing to use test product throughout the study period.
Exclusion criteria
Exclusion criteria: 1) History of any dermatological condition of the skin diseases. 2) Subject with present condition of allergic response to any cosmetic product. 3) Subject having allergic response to the ink. 4) Presence of any broken, chapped, cut, irritated, or scraped skin at the application site. 5) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study. 6) Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment. 7) Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study. 8) History of alcohol or drug addiction. 9) Subjects using other marketed products during the study period. 10) Any other condition which could warrant exclusion from the study, as per the dermatologist s/investigator s discretion. 11) Pregnant or breastfeeding or planning to become pregnant during the study period. 12) History of chronic illness which may influence the cutaneous state. 13) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test product 1. change in Urticaria 2.change in Pruritus 3.change in skin hydration 4.change in DASI score 5.change in overall dry skin score (ODS) 6.change in skin barrier function 7.change in skin roughness, skin scaliness, skin smoothness and skin wrinkles Timepoint: Baseline before usage of the test product on Day 01 and after usage of the test product at T2 hours on Day 01, Day 15, and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test product in terms of 1. change in skin itchiness and redness 2.change in visual and tactile assessment 3.subject perception questionnaireTimepoint: Baseline before usage of the test product on Day 01 and after usage of the test product at T2 hours on Day 01, Day 15, and Day 30 | — |
Countries
India
Contacts
Public ContactMaheshvari N Patel
NovoBliss Research Private Limited
Outcome results
None listed