Normal SkinNCT06631898
To Check Dermatological Safety of Test Products by 24 Hours Patch Test on Adult Healthy Human Subjects.
A study testing SaaTwae Bio-Natural Moisturizing Cream in people with Normal Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
This is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion or semi occlusion or open patch for at least 24 hours (± 2 hours). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Skin
- What is being tested?
- SaaTwae Bio-Natural Moisturizing Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- 9 Oct 2024to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Age: 18-65 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- 3) Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
- 4) Females of childbearing potential must have a self-reported negative pregnancy test.
- 5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- 6) Subject is in good general health as determined by the Investigator on the basis of medical history.
- 7) Subjects is willing to maintain the test patches in designated positions for 24 Hours.
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- 8) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- 9) Subject must be able to understand and provide written informed consent to participate in the study.
- 10) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
Who cannot join
- 1) Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
- 2) Medication which may affect skin response and/or past medical history. 3) Subject having history of diabetes 4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- 5) Subject suffering from any active clinically significant skin diseases which may contraindicate.
- 6) Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
- 7) Participation in any patch test for irritation or sensitization within the last four weeks.
- 8) Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
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- 9) Use of any: i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
- Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted) 10) Topical drugs used at application site. 11) Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
- 12) Individual who has a medical condition or is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
- 13) Subject with known allergy or sensitization to medical adhesives, bandages. 14) Participation in other patch study simultaneously.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion or Semi Occlusion or Open Patch on Adult Healthy Human Subjects.
This is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion or semi occlusion or open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event A sufficient number 26 subject will be enrolled to get 24 completed the study. There are total three visits in this study and are optional visit pre-screening visit : Lactic Acid Stinging test\& Modified Dr baumenn's skin type questionnaire. Visit 01: Screening, Enrollment, and Patch Application (Day 01) Visit 02: Patch Removal After 24 hours of Application \& 30 ± 5 min irritation scoring upon patch removal Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery (optional deemed necessary) Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)
- Conditions
- Normal Skin
- Being tested
- SaaTwae Bio-Natural Moisturizing Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaaTwae Bio-Natural Moisturizing CreamOther
A 0.04 gm of test products along with controls (negative and positive) will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch.
| Study group | Role | What they receive |
|---|---|---|
| SaaTwae Bio-Natural Moisturizing Cream | Experimental | A 0.04 gm of test products along with controls (negative and positive) will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch. Receives: Other: SaaTwae Bio-Natural Moisturizing Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the dermatological safety of the test products by 24 Hours Patch Test
Dermatological safety of the test products by 24 Hours Patch Test will be evaluated by 0: No reaction and 4 Severe Reaction
Measured: Irritation Scoring at T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if needed.
Secondary outcomes (1)
Safety of the skin
To evaluate the Safety of the skin by visual dermatological assessment by 0: No reaction and 4 Severe Reaction
Measured: At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start9 Oct 2024
- Primary completion11 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal 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
- Primary Irritation Patch Test Study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Blossom Microbiotics LLC
- Responsible party
- Sponsor
- Investigators
- Dr. Nayan K Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631898
- Sponsor's protocol ID
- NB240048-BM
- Status last verified
- Feb 2025
- First submitted
- 2 Oct 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion or Semi Occlusion or Open Patch on Adult Healthy Human Subjects.
- ClinicalTrials.gov ID
- NCT06631898
- Acronym / sponsor ID
- NB240048-BM
- Conditions
- Normal Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Blossom Microbiotics LLC
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 8 Oct 2024 (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 is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion or semi occlusion or open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event A sufficient number 26 subject will be enrolled to get 24 completed the study. There are total three visits in this study and are optional visit pre-screening visit : Lactic Acid Stinging test\& Modified Dr baumenn's skin type questionnaire. Visit 01: Screening, Enrollment, and Patch Application (Day 01) Visit 02: Patch Removal After 24 hours of Application \& 30 ± 5 min irritation scoring upon patch removal Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery (optional deemed necessary) Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Primary Irritation Patch Test Study
| Arm | Type | Receives |
|---|---|---|
| SaaTwae Bio-Natural Moisturizing Cream | Experimental | Other: SaaTwae Bio-Natural Moisturizing CreamA 0.04 gm of test products along with controls (negative and positive) will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1) Age: 18-65 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- 3) Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
- 4) Females of childbearing potential must have a self-reported negative pregnancy test.
- 5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- 6) Subject is in good general health as determined by the Investigator on the basis of medical history.
Key exclusion criteria (11 listed)
- 1) Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
- 2) Medication which may affect skin response and/or past medical history. 3) Subject having history of diabetes 4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- 5) Subject suffering from any active clinically significant skin diseases which may contraindicate.
- 6) Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
- 7) Participation in any patch test for irritation or sensitization within the last four weeks.
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 |
|---|---|---|
| SaaTwae Bio-Natural Moisturizing CreamA 0.04 gm of test products along with controls (negative and positive) will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch. | Other | SaaTwae Bio-Natural Moisturizing Cream |
Primary outcome
To evaluate the dermatological safety of the test products by 24 Hours Patch Test
Time frame: Irritation Scoring at T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if needed.
Dermatological safety of the test products by 24 Hours Patch Test will be evaluated by 0: No reaction and 4 Severe Reaction
1 secondary outcome
Safety of the skin
Time frame: At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 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. This study is not recruiting at the moment.
Dr. Nayan K Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaaTwae Bio-Natural Moisturizing Cream in people with Normal Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the dermatological safety of the test products by 24 Hours Patch Test (time frame: Irritation Scoring at T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if needed.). 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 28 Feb 2025.