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Hexarelin

Examorelin, HEX

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Studies 233
Trials 61
Not Yet Recruiting NA INTERVENTIONAL 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

View on ClinicalTrials.gov Updated Dec 15, 2025

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

Name: Utixira Lotion tablet as regimen
Type: OTHER
Description: 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

Primary Outcomes

Measure: 1. To evaluate the effectiveness of the test product in terms of change in Urticaria
TimeFrame: after usage of the test product at T2 hours on Day 01, Day 15 (+2 Days), and Day 30 (+2 Days)
Description: UAS7 scoring scale where 0= urticaria free and 28-42 = severe urticaria
Measure: 2. To evaluate the effectiveness of test product in terms of change in skin Pruritus (itching)
TimeFrame: 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)
Description: VAS scale where 0 = No pruritus (itching) and 10= very severe pruritus (itching)
Measure: 3. To assess the effectiveness of test product in terms of change in skin hydration
TimeFrame: 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)
Description: Instrumental Evaluation: Corneometer CM 825
Measure: 4. To assess the effectiveness of the test product in terms of change in DASI (Dry area and severity index) score
TimeFrame: 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)
Description: Scoring Scale: 0: absent, 4: extreme
Measure: 5. To assess the effectiveness of the test product in terms of change in overall dry skin score
TimeFrame: 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)
Description: Scoring Scale: 0: absent, 4: Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks
Measure: 6. To evaluate the effectiveness of the test product in terms of change in skin barrier function
TimeFrame: 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)
Description: Instrumental Evaluation: TEWAMeter TM Hex
Measure: 7. To evaluate the effectiveness of the test product in terms of change in skin roughness
TimeFrame: 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)
Description: Instrumental Evaluation: VISIOSCAN VC 20 Plus
Measure: 8. To evaluate the effectiveness of the test product in terms of change in skin scaliness
TimeFrame: 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)
Description: Instrumental Evaluation: VISIOSCAN VC 20 Plus
Measure: 9. To evaluate the effectiveness of the test product in terms of change in skin smoothness
TimeFrame: 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)
Description: Instrumental Evaluation: VISIOSCAN VC 20 Plus
Measure: 10. To evaluate the effectiveness of the test product in terms of change in skin wrinkles
TimeFrame: 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)
Description: Instrumental Evaluation: VISIOSCAN VC 20 Plus

Trial Information

NCT ID

NCT06924840

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

SAVA Healthcare Limited

Last Updated

December 15, 2025