Dry SkinNCT06924840
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 study testing Utixira Lotion tablet as regimen in people with Dry Skin and Urticaria, run by SAVA Healthcare Limited.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Utixira Lotion tablet as regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sheetal Khandwala contact
About this study
Official title: 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
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
Read the 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
- Being tested
- Utixira Lotion tablet as regimen
- Medical subject headings
- Urticaria, Pruritus, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utixira Lotion tablet as regimenOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Utixira Lotion tablet as regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
VAS scale where 0 = No redness and 10= very severe redness
Measured: 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
0= Absent 4= extreme
Measured: 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
0= Absent 4= extreme
Measured: 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
0= Absent 4= extreme
Measured: 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
0= none 4= severe
Measured: 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 scaliness
0= Absent 4= extreme
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SAVA Healthcare Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924840
- Sponsor's protocol ID
- NB250006-SG
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06924840
- Acronym / sponsor ID
- NB250006-SG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- SAVA Healthcare LimitedUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Utixira Lotion tablet as regimen | Experimental | Other: Utixira Lotion tablet as regimenMode 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Utixira Lotion tablet as regimenMode 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 | Other | Utixira Lotion tablet as regimen |
Primary outcome
1. To evaluate the effectiveness of the test product in terms of change in Urticaria
Time frame: after usage of the test product at T2 hours on Day 01, Day 15 (+2 Days), and Day 30 (+2 Days)
UAS7 scoring scale where 0= urticaria free and 28-42 = severe urticaria
2. To evaluate the effectiveness of test product in terms of change in skin Pruritus (itching)
Time frame: 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)
VAS scale where 0 = No pruritus (itching) and 10= very severe pruritus (itching)
3. To assess the effectiveness of test product in terms of change in skin hydration
Time frame: 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)
Instrumental Evaluation: Corneometer CM 825
4. To assess the effectiveness of the test product in terms of change in DASI (Dry area and severity index) score
Time frame: 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)
Scoring Scale: 0: absent, 4: extreme
5. To assess the effectiveness of the test product in terms of change in overall dry skin score
Time frame: 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)
Scoring Scale: 0: absent, 4: Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks
6. To evaluate the effectiveness of the test product in terms of change in skin barrier function
Time frame: 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)
Instrumental Evaluation: TEWAMeter TM Hex
7. To evaluate the effectiveness of the test product in terms of change in skin roughness
Time frame: 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)
Instrumental Evaluation: VISIOSCAN VC 20 Plus
8. To evaluate the effectiveness of the test product in terms of change in skin scaliness
Time frame: 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)
Instrumental Evaluation: VISIOSCAN VC 20 Plus
9. To evaluate the effectiveness of the test product in terms of change in skin smoothness
Time frame: 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)
Instrumental Evaluation: VISIOSCAN VC 20 Plus
10. To evaluate the effectiveness of the test product in terms of change in skin wrinkles
Time frame: 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)
Instrumental Evaluation: VISIOSCAN VC 20 Plus
6 secondary outcomes
To assess the effectiveness of the test product in terms of change in redness score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 scaliness
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheetal Khandwala contact
Nayan Patel principal investigator
NovoBliss Research Private Limited
Questions about this trial
What is this clinical trial studying?
A study testing Utixira Lotion tablet as regimen in people with Dry Skin and Urticaria, run by SAVA Healthcare Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maheshvari N Patel (09909013286, maheshvari@novobliss.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To evaluate the effectiveness of the test product in terms of change in Urticaria (time frame: after usage of the test product at T2 hours on Day 01, Day 15 (+2 Days), and Day 30 (+2 Days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.