An interventional study of Utixira Lotion tablet as regimen in Dry Skin, Urticaria and Pruritus, sponsored by SAVA Healthcare Limited. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by SAVA Healthcare Limited · Not applicable, Interventional, and Other
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 (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.
147 studies on the registry are indexed under Urticaria; 19 are open to participants now.
This study's planned enrollment of 32 is below the median of 51 across 104 interventional studies indexed under Urticaria.
Browse Urticaria studies →SAVA Healthcare Limited is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Time frame: 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)
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)
3. To assess the effectiveness of test product in terms of change in skin hydration
Instrumental Evaluation: Corneometer CM 825
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)
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
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)
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
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)
6. To evaluate the effectiveness of the test product in terms of change in skin barrier function
Instrumental Evaluation: TEWAMeter TM Hex
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)
7. To evaluate the effectiveness of the test product in terms of change in skin roughness
Instrumental Evaluation: VISIOSCAN VC 20 Plus
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)
8. To evaluate the effectiveness of the test product in terms of change in skin scaliness
Instrumental Evaluation: VISIOSCAN VC 20 Plus
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)
9. To evaluate the effectiveness of the test product in terms of change in skin smoothness
Instrumental Evaluation: VISIOSCAN VC 20 Plus
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)
10. To evaluate the effectiveness of the test product in terms of change in skin wrinkles
Instrumental Evaluation: VISIOSCAN VC 20 Plus
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 redness score
VAS scale where 0 = No redness and 10= very severe 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 skin dryness
0= Absent 4= extreme
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
0= Absent 4= extreme
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
0= Absent 4= extreme
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
0= none 4= severe
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
0= Absent 4= extreme
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)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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SAVA Healthcare Limited