A Clinical Study to Assess the Safety and Effectiveness of Utixira Lotion and Utixira Tablet in Healthy Adult Human Subjects With Dry or Sensitive Skin Prone to Mild to Moderate Pruritus and Urticaria

A Clinical Evaluation of the Safety, In-Use Tolerability, and Efficacy of the Utixira Lotion and Utixira Tablet Combination Regimen in Healthy Adults With Dry, Sensitive Skin Prone to Mild to Moderate Pruritus and Urticaria

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pruritus; Urticaria; Dry Skin; Sensitive
• Intervention / Treatment: Other: Utixira Lotion tablet as regimen

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

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maheshvari N Patel; Phone Number: 09909013286; Email: maheshvari@novobliss.in
• Study Contact Backup: Name: Sheetal Khandwala; Email: bd@novobliss.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Utixira 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 tablet twice a day for better results. Marketed By: SAVA Healthcare Ltd Frequency: Twice a Day	Other: Utixira 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)
3. To assess the effectiveness of test product in terms of change in skin hydration	Instrumental Evaluation: Corneometer CM 825	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)
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	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)
5. To assess the effectiveness of the test product in terms of change in overall dry skin score	Scoring Scale: 0: absent, 4: Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks	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)
6. To evaluate the effectiveness of the test product in terms of change in skin barrier function	Instrumental Evaluation: TEWAMeter TM Hex	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)
9. To evaluate the effectiveness of the test product in terms of change in skin smoothness	Instrumental Evaluation: VISIOSCAN VC 20 Plus	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)
10. To evaluate the effectiveness of the test product in terms of change in skin wrinkles	Instrumental Evaluation: VISIOSCAN VC 20 Plus	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)
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	after usage of the test product at T2 hours on Day 01, Day 15 (+2 Days), and Day 30 (+2 Days)
7. To evaluate the effectiveness of the test product in terms of change in skin roughness	Instrumental Evaluation: VISIOSCAN VC 20 Plus	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)
8. To evaluate the effectiveness of the test product in terms of change in skin scaliness	Instrumental Evaluation: VISIOSCAN VC 20 Plus	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)
To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness	0= Absent 4= extreme	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)
To assess the effectiveness of the test product in terms of change in visual assessment of skin roughness	0= Absent 4= extreme	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)
To assess the effectiveness of the test product in terms of change in visual assessment of skin redness	0= Absent 4= extreme	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)
To assess the effectiveness of the test product in terms of change in visual assessment of ski itchiness	0= none 4= severe	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)
To assess the effectiveness of the test product in terms of change in visual assessment of skin scaliness	0= Absent 4= extreme	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)

Collaborators and Investigators

• Sponsor: SAVA Healthcare Limited
• Investigators: Principal Investigator: Nayan Patel, NovoBliss Research Private Limited

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Skin Manifestations; Hypersensitivity, Immediate; Skin Diseases; Skin Diseases, Vascular; Hypersensitivity; Pruritus; Urticaria
• Other Study ID Numbers: NB250006-SG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No