Dry Skin, Pruritus, Sensitive, Urticaria
Conditions
Brief summary
This exploratory, prospective, open-label, single-centre, safety, efficacy and in-use tolerability study of the Utixira Lotion + Utixira Lotion as regimen in healthy adult human subjects with dry or sensitive skin and prone to mild to moderate pruritus or urticaria
Detailed description
A total of up to 32 healthy male and non-pregnant \| non-lactating female (21 subjects with dry or sensitive skin and 11 subjects of pruritus/urticaria patients) and an age of 18-55 years will be enrolled to complete the 30 subjects the study (20 subjects with dry or sensitive skin and 10 subjects of pruritus/urticaria patients). The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called telephonically by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult female subjects will be instructed to visit the facility as per the below visits. * Visit 01 (Day 01): Screening, Enrollment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation * Visit 02 (Day 15 +2 Days): Evaluations, Product usage period * Visit 03 (Day 30 +2 Days): Evaluations, End of the Study
Interventions
OTHERUtixira Lotion tablet as regimen
Mode of Usage: To be applied over the affected areas twice a day as a thin film and rubbed in gently and completely. Take 1 capsule twice a day for better results. Marketed By: SAVA Healthcare Ltd Frequency: Twice a Day
Sponsors
SAVA Healthcare Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Utixira Lotion and Tablet Mode of Usage: To be applied over the affected areas twice a day as a thin film and rubbed in gently and completely. take 1 tablet twice a day for better results.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 to 55 years (both inclusive) at the time of consent. * Sex: Healthy male and non-pregnant/non-lactating females. * Females of childbearing potential must have a self-reported negative pregnancy test. * Subject are generally in good health. * Subject with dry or sensitive skin at a time of screening. (Dermatological Assessment) * Subjects having pruritus or urticaria at a time of screening. * Subjects application site must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds. * 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. * 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. * Subjects are willing to give written informed consent and are willing to come for regular follow up. * Subjects who commit not to use medicated skincare product other than the test product for the entire duration of the study. * Subject who have not participated in a similar investigation in the past three months. * Willing to use test product throughout the study period.
Exclusion criteria
* History of any dermatological condition of the skin diseases. * Subject with present condition of allergic response to any cosmetic product. * Subject having allergic response to the ink. * Presence of any broken, chapped, cut, irritated, or scraped skin at the application site. * Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study. * Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment. 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. * History of alcohol or drug addiction. * Subjects using other marketed products during the study period. * Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion. * Pregnant or breastfeeding or planning to become pregnant during the study period. * History of chronic illness which may influence the cutaneous state. * Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10. To evaluate the effectiveness of the test product in terms of change in skin wrinkles | from 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 (+2 Days), and Day 30 (+2 Days) | Instrumental Evaluation: VISIOSCAN VC 20 Plus |
| 4. To assess the effectiveness of the test product in terms of change in DASI (Dry area and severity index) score | from 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 (+2 Days), and Day 30 (+2 Days) | Scoring Scale: 0: absent, 4: extreme |
| 5. To assess the effectiveness of the test product in terms of change in overall dry skin score | from 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 (+2 Days), and Day 30 (+2 Days) | Scoring Scale: 0: absent, 4: Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks |
| 6. To evaluate the effectiveness of the test product in terms of change in skin barrier function | from 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 (+2 Days), and Day 30 (+2 Days) | Instrumental Evaluation: TEWAMeter TM Hex |
| 7. To evaluate the effectiveness of the test product in terms of change in skin roughness | from 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 (+2 Days), and Day 30 (+2 Days) | Instrumental Evaluation: VISIOSCAN VC 20 Plus |
| 8. To evaluate the effectiveness of the test product in terms of change in skin scaliness | from 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 (+2 Days), and Day 30 (+2 Days) | Instrumental Evaluation: VISIOSCAN VC 20 Plus |
| 9. To evaluate the effectiveness of the test product in terms of change in skin smoothness | from 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 (+2 Days), and Day 30 (+2 Days) | Instrumental Evaluation: VISIOSCAN VC 20 Plus |
| 1. To evaluate the effectiveness of the test product in terms of change in Urticaria | after usage of the test product at T2 hours on Day 01, Day 15 (+2 Days), and Day 30 (+2 Days) | UAS7 scoring scale where 0= urticaria free and 28-42 = severe urticaria |
| 2. To evaluate the effectiveness of test product in terms of change in skin Pruritus (itching) | From 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 (+2 Days), and Day 30 (+2 Days) | VAS scale where 0 = No pruritus (itching) and 10= very severe pruritus (itching) |
| 3. To assess the effectiveness of test product in terms of change in skin hydration | from 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 (+2 Days), and Day 30 (+2 Days) | Instrumental Evaluation: Corneometer CM 825 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness | from 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 (+2 Days), and Day 30 (+2 Days) | 0= Absent 4= extreme |
| To assess the effectiveness of the test product in terms of change in visual assessment of skin roughness | from 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 (+2 Days), and Day 30 (+2 Days) | 0= Absent 4= extreme |
| To assess the effectiveness of the test product in terms of change in visual assessment of skin redness | from 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 (+2 Days), and Day 30 (+2 Days) | 0= Absent 4= extreme |
| To assess the effectiveness of the test product in terms of change in visual assessment of ski itchiness | from 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 (+2 Days), and Day 30 (+2 Days) | 0= none 4= severe |
| To assess the effectiveness of the test product in terms of change in visual assessment of skin scaliness | from 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 (+2 Days), and Day 30 (+2 Days) | 0= Absent 4= extreme |
| To assess the effectiveness of the test product in terms of change in redness score | from 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 (+2 Days), and Day 30 (+2 Days) | VAS scale where 0 = No redness and 10= very severe redness |
Contacts
Primary ContactMaheshvari N Patel
Backup ContactSheetal Khandwala
Outcome results
None listed