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

NCT06924840 | Not Yet Recruiting

• 1 other identifier: NB250006-SG
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dry Skin; Urticaria; Pruritus; Sensitive

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (6)

• To assess the effectiveness of the test product in terms of change in redness score

  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

  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

  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

  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

  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)

Study Arms (1)

Utixira Lotion tablet as regimen

EXPERIMENTAL

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

Interventions

Utixira Lotion tablet as regimen OTHER

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

Utixira Lotion tablet as regimen

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SAVA Healthcare Limited: lead

MeSH Terms

Conditions

Urticaria; Pruritus; Hypersensitivity

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Nayan Patel

  NovoBliss Research Private Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013286; maheshvari@novobliss.in

Sheetal Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Utixira Lotion and Tablet 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.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: May 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share