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
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.
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.
Single group
Utixira Lotion tablet as regimen
Other interventionMode 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
1. To evaluate the effectiveness of the test product in terms of change in Urticaria
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)
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
Instrumental Evaluation: Corneometer CM 825
4. To assess the effectiveness of the test product in terms of change in DASI (Dry area and severity index) score
Scoring Scale: 0: absent, 4: extreme
To assess the effectiveness of the test product in terms of change in redness score
VAS scale where 0 = No redness and 10= very severe redness
To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness
0= Absent 4= extreme
To assess the effectiveness of the test product in terms of change in visual assessment of skin roughness
0= Absent 4= extreme
To assess the effectiveness of the test product in terms of change in visual assessment of skin redness
0= Absent 4= extreme
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