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

Launched by SAVA HEALTHCARE LIMITED · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of two products called Utixira Lotion and Utixira Tablet, designed for healthy adults with dry or sensitive skin that is prone to mild to moderate itching (pruritus) and hives (urticaria). The goal is to see how well these products work for people who have these skin conditions. The trial is not yet recruiting participants, but it will include adults aged 18 to 55 who are generally in good health and have dry or sensitive skin with itching or hives.

To be eligible, participants must be healthy males or non-pregnant females, and women of childbearing age must have a negative pregnancy test and agree to use birth control during the study. Participants will need to avoid using other medicated skincare products while taking part in the trial. If you decide to join, you can expect regular follow-up visits to monitor your skin's condition and how well the products are working. Overall, this study aims to help improve treatments for people with dry or sensitive skin.

Gender

ALL

Eligibility criteria

• 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.