NCT06924840

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: SAVA Healthcare Limited · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Dry Skin
• Urticaria
• Pruritus
• Sensitive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-15
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2025-04-11
• Last updated: 2025-04-18