| CTRI Number |
CTRI/2025/04/084963 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety and Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of test product in healthy adult subjects |
|
Scientific Title of Study
|
A Clinical Evaluation of the Safety, In-Use Tolerability, and Efficacy of the Utirixia Lotion and Utirixia Tablet Combination Regimen in Healthy Adults with Dry, Sensitive Skin Prone to Mild to Moderate Pruritus and Urticaria |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250006-SG, Ver 1.0, 25 Mar 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alka Makawana |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari N Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| SAVA House, Lalwani Plaza, Wing B,
Off Airport Road, Sakore Nagar,
Viman Nagar, Pune - 411014 India |
|
|
Primary Sponsor
|
| Name |
SAVA Healthcare Limited |
| Address |
SAVA House, Lalwani Plaza, Wing B, Off Airport Road, Sakore Nagar, Viman Nagar, Pune - 411014 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Pvt. Limited |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dry or sensitive skin,
Pruritus or Urticaria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not Applicable |
| Intervention |
Utixira Lotion
|
Mode of Usage: To be applied over the affected areas twice a day as a thin film and rubbed in gently and completely.
Duration: 30 days
Frequency: Twice a Day
Route of Administration: Topical
Dose: Required amount
Dosage form: Lotion
|
| Intervention |
Utixira tablet |
Mode of Usage: 1 tablet twice a day after meals.
Frequency: Twice a day
Dose: single tablet
Dosage Form: Tablet
Duration: 30 days
Route of administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 to 55 years (both inclusive) at the time of consent.
2) Sex: Healthy male and non-pregnant/non-lactating females.
3) Females of childbearing potential must have a self-reported negative pregnancy test.
4) Subject are generally in good health.
5) Subject with dry or sensitive skin at a time of screening. (Dermatological Assessment)
6) Subjects having pruritus or urticaria at a time of screening.
7) Subjects assessment site must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds.
8) 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.
9) 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.
10) Subjects are willing to give written informed consent and are willing to come for regular follow up.
11) Subjects who commit not to use medicated skincare product other than the test product for the entire duration of the study.
12) Subject who have not participated in a similar investigation in the past three months.
13) Willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1) History of any dermatological condition of the skin diseases.
2) Subject with present condition of allergic response to any cosmetic product.
3) Subject having allergic response to the ink.
4) Presence of any broken, chapped, cut, irritated, or scraped skin at the application site.
5) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
6) Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment.
7) 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.
8) History of alcohol or drug addiction.
9) Subjects using other marketed products during the study period.
10) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
11) Pregnant or breastfeeding or planning to become pregnant during the study period.
12) History of chronic illness which may influence the cutaneous state.
13) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test product
1. change in Urticaria
2.change in Pruritus
3.change in skin hydration
4.change in DASI score
5.change in overall dry skin score (ODS)
6.change in skin barrier function
7.change in skin roughness, skin scaliness, skin smoothness and skin wrinkles
|
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, and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test product in terms of
1. change in skin itchiness and redness
2.change in visual and tactile assessment
3.subject perception questionnaire |
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, and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2025 |
| Date of Study Completion (India) |
16/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. A total of up to 32 healthy male and
non-pregnant | non-lactating female and an age of 18-55 years will be enrolled to
complete the 30 subjects the study. -
Visit 01 (Day 01): Screening, Enrollment,
Baseline Evaluation, On Site Product Usage, Post Usage Evaluation
-
Visit 02 (Day 15): Evaluations, Product usage period
-
Visit 03 (Day 30): Evaluations, End of the Study |