HealthyNCT05642702
Primary Irritation Patch Test (PIPT) Study Conducted at NovoBliss Research for Shared Panel
A study testing Peptide complexed HA Age Defying Gel with Vitamin C & Niacinamide, Peptide complexed HA Age Defying Gel with Natural Extracts and Peptide complexed HA Age Defying Gel with Vitamin C & Natural Extracts in people with Healthy, run by NovoBliss Research Pvt Ltd.
Trial summary
This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion 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
- Healthy
- What is being tested?
- Peptide complexed HA Age Defying Gel with Vitamin C & Niacinamide, Peptide complexed HA Age Defying Gel with Natural Extracts and Peptide complexed HA Age Defying Gel with Vitamin C & Natural Extracts
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2022to 20 Dec 2022
- 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
- Age: 18-65 years (both inclusive) at the time of consent.
- Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
- Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- Subject is in good general health as determined by the Investigator on the basis of medical history.
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- Subjects is willing to maintain the test patches in designated positions for 24 Hours.
- Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- Subject must be able to understand and provide written informed consent to participate in the study.
- Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
Who cannot join
- 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.
- Medication which may affect skin response and/or past medical history.
- Subject having history of diabetes
- 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.
- Subject suffering from any active clinically significant skin diseases which may contraindicate.
- Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
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- Participation in any patch test for irritation or sensitization within the last four weeks.
- Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
- Use of any:
- 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)
- Topical drugs used at application site.
- Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
- 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.
- Subject with known allergy or sensitization to medical adhesives, bandages.
- Participation in other patch study simultaneously.
Trial locations and contacts
No sites are listed yet.
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 a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events.
The subject's back between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and edema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.
Read the detailed description
The objective of this study is to evaluate the dermatological safety of the test products by 24 Hours patch test under complete occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal, and Combination).
This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events. The subject's back i.e. between the scapula and waist will be utilized as application sites.
26 subjects with varied skin types (Oily, Dry, Normal, and Combination, preferably equal ratio) will be enrolled in the study to get 24 completed subjects at the end of study.
The expected total study duration will be approximately 9 days from patch application day.
The duration of this study will be 9 days from enrollment day. There are total of 3 visits in this study and one optional visit.
- 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 (Day 02)
- Visit 03: 24 (± 2) hours Irritation Scoring (Day 03) after patch removal
- Visit 04: The subject will be contacted telephonically on Day 08 for any signs of irritation at the patch application site. Follow-up visit for reactions if any to confirm recovery (Optional, if deemed necessary) [Irritation scoring at 168±2 hours post-patch removal (Day 09)].
Application Sites (Back) will be evaluated for scoring the reaction, namely, erythema, dryness, wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30 + 5 minutes of patch removal (Day 02), 24±2 hours (Day 03) and 168±2 hours (Day 09) after the patch removal.
Scoring data will be updated in tabular format and mean irritation scoring will be obtained from irritation scores and the same will be included in the final Product Summary Report for all test products after completion of the study.
Demographic characteristics and results of the study will be summarized. Any AEs will be summarized with a number and a percentage.
Four parameters namely erythema, dryness, wrinkles and oedema will be scored separately on the irritation scoring sheet. Irritation scoring data will be updated in tabular format. Data of each subject that has completed the initial 03 study visits i.e. Day 01, Day 02, and Day 03 of the study will be considered for Mean Irritation Score Derivation. Mean Irritation Score (MIS) and standard deviation will be calculated using a standard statistical formula for each product. The Product irritancy level will be classified and reported based on the classification of Mean Irritation Score per sec#17.1. Standard deviation will be calculated to provide variability of data.
For calculation of Mean Irritation Score of erythema, dryness and wrinkles the highest score will be taken.
MIS = Total score (highest score from Erythema, dryness, wrinkles + Oedema) for each test product / Total no. of Subjects.
- Conditions
- Healthy
- Being tested
- Peptide complexed HA Age Defying Gel with Vitamin C & Niacinamide, Peptide complexed HA Age Defying Gel with Natural Extracts, Peptide complexed HA Age Defying Gel with Vitamin C & Natural Extracts, 1% w/v Sodium Lauryl Sulphate (SLS) solution, Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide complexed HA Age Defying Gel with Vitamin C & NiacinamideOther
Also called Skin Care product
Semi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape.
Peptide complexed HA Age Defying Gel with Natural ExtractsOther
Also called Skin Care product
Semi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape.
Peptide complexed HA Age Defying Gel with Vitamin C & Natural ExtractsOther
Also called Skin Care product
Semi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape.
1% w/v Sodium Lauryl Sulphate (SLS) solutionOther
Also called Positive Control
1g of Sodium Lauryl Sulphate will be dissolved in distilled water and made up to 100 mL solution using distilled water. A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape.
Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/vOther
Also called Negative Control
A 0.04 mL of 0.9% w/v solution of Isotonic Saline Solution will be dispensed on the center of an appropriately sized filter paper, which will be further placed in the designated IQ/Finn chambers prefixed to a micropore tape.
| Study group | Role | What they receive |
|---|---|---|
| Test Product Code A | Experimental | Peptide complexed HA Age Defying Gel with Vitamin C \& Niacinamide - Receives: Other: Peptide complexed HA Age Defying Gel with Vitamin C & Niacinamide |
| Test Product Code B | Experimental | Peptide complexed HA Age Defying Gel with Natural Extracts Receives: Other: Peptide complexed HA Age Defying Gel with Natural Extracts |
| Test Product Code C | Experimental | Peptide complexed HA Age Defying Gel with Vitamin C \& Natural Extracts Receives: Other: Peptide complexed HA Age Defying Gel with Vitamin C & Natural Extracts |
| Positive Control | Active comparator | Sodium Lauryl Sulphate (SLS) analytical grade 1 % w/v Receives: Other: 1% w/v Sodium Lauryl Sulphate (SLS) solution |
| Negative Control | Active comparator | Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v Receives: Other: Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Irritation Potential of the test product from Baseline to Post application
To evaluate the dermatological irritation potential of the test products by applying Patch Test Under Complete Occlusion for continuous 24 Hours exposure on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination)
Measured: Irritation Scoring at 30 minutes, and 24 hours, 168 hours post patch removal.
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence of Treatment-Emergent Adverse Events regarding acute strong dermal reactions such as dryness, swelling, redness, scaling reported, during the clinical conduct on Day1, 2, 3 and day 7 post patch removal and entire study duration.
Measured: At 30 minutes (on Day2) and 24 hours (on Day 3) post patch removal and up to 9 days from the Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start5 Dec 2022 (estimated)
- Primary completion13 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Nanobrid Innovations Private Limited
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr Nayan K Patel, MBBS, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642702
- Sponsor's protocol ID
- NBSP22-PIPT
- Other IDs
- NBSP22-PIPT-0030-NI
- Status last verified
- Dec 2022
- First submitted
- 12 Nov 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. 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
- NCT05642702
- Acronym / sponsor ID
- NBSP22-PIPT
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Nanobrid Innovations Private Limited
- Study start
- 5 Dec 2022 (estimated)
- Primary completion
- 13 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 8 Dec 2022 (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 a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events.
The subject's back between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and edema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.
Detailed description
The objective of this study is to evaluate the dermatological safety of the test products by 24 Hours patch test under complete occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal, and Combination).
This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events. The subject's back i.e. between the scapula and waist will be utilized as application sites.
26 subjects with varied skin types (Oily, Dry, Normal, and Combination, preferably equal ratio) will be enrolled in the study to get 24 completed subjects at the end of study.
The expected total study duration will be approximately 9 days from patch application day.
The duration of this study will be 9 days from enrollment day. There are total of 3 visits in this study and one optional visit.
- 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 (Day 02)
- Visit 03: 24 (± 2) hours Irritation Scoring (Day 03) after patch removal
- Visit 04: The subject will be contacted telephonically on Day 08 for any signs of irritation at the patch application site. Follow-up visit for reactions if any to confirm recovery (Optional, if deemed necessary) [Irritation scoring at 168±2 hours post-patch removal (Day 09)].
Application Sites (Back) will be evaluated for scoring the reaction, namely, erythema, dryness, wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30 + 5 minutes of patch removal (Day 02), 24±2 hours (Day 03) and 168±2 hours (Day 09) after the patch removal.
Scoring data will be updated in tabular format and mean irritation scoring will be obtained from irritation scores and the same will be included in the final Product Summary Report for all test products after completion of the study.
Demographic characteristics and results of the study will be summarized. Any AEs will be summarized with a number and a percentage.
Four parameters namely erythema, dryness, wrinkles and oedema will be scored separately on the irritation scoring sheet. Irritation scoring data will be updated in tabular format. Data of each subject that has completed the initial 03 study visits i.e. Day 01, Day 02, and Day 03 of the study will be considered for Mean Irritation Score Derivation. Mean Irritation Score (MIS) and standard deviation will be calculated using a standard statistical formula for each product. The Product irritancy level will be classified and reported based on the classification of Mean Irritation Score per sec#17.1. Standard deviation will be calculated to provide variability of data.
For calculation of Mean Irritation Score of erythema, dryness and wrinkles the highest score will be taken.
MIS = Total score (highest score from Erythema, dryness, wrinkles + Oedema) for each test product / Total no. of Subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Test Product Code A | Experimental | Other: Peptide complexed HA Age Defying Gel with Vitamin C & NiacinamidePeptide complexed HA Age Defying Gel with Vitamin C \& Niacinamide - |
| Test Product Code B | Experimental | Other: Peptide complexed HA Age Defying Gel with Natural ExtractsPeptide complexed HA Age Defying Gel with Natural Extracts |
| Test Product Code C | Experimental | Other: Peptide complexed HA Age Defying Gel with Vitamin C & Natural ExtractsPeptide complexed HA Age Defying Gel with Vitamin C \& Natural Extracts |
| Positive Control | Active comparator | Other: 1% w/v Sodium Lauryl Sulphate (SLS) solutionSodium Lauryl Sulphate (SLS) analytical grade 1 % w/v |
| Negative Control | Active comparator | Other: Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/vSodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18-65 years (both inclusive) at the time of consent.
- Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
- Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
Key exclusion criteria (17 listed)
- 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.
- Medication which may affect skin response and/or past medical history.
- Subject having history of diabetes
- 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.
- Subject suffering from any active clinically significant skin diseases which may contraindicate.
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 |
|---|---|---|
| Peptide complexed HA Age Defying Gel with Vitamin C & NiacinamideAlso: Skin Care productSemi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape. | Other | Test Product Code A |
| Peptide complexed HA Age Defying Gel with Natural ExtractsAlso: Skin Care productSemi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape. | Other | Test Product Code B |
| Peptide complexed HA Age Defying Gel with Vitamin C & Natural ExtractsAlso: Skin Care productSemi Solid, Hydrophilic - Gel, A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape. | Other | Test Product Code C |
| 1% w/v Sodium Lauryl Sulphate (SLS) solutionAlso: Positive Control1g of Sodium Lauryl Sulphate will be dissolved in distilled water and made up to 100 mL solution using distilled water. A 0.04 mL of test sample will be dispensed onto the center of an appropriately sized filter paper will be placed in the designated IQ/Finn chambers prefixed to a micropore tape. | Other | Positive Control |
| Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/vAlso: Negative ControlA 0.04 mL of 0.9% w/v solution of Isotonic Saline Solution will be dispensed on the center of an appropriately sized filter paper, which will be further placed in the designated IQ/Finn chambers prefixed to a micropore tape. | Other | Negative Control |
Primary outcome
Change from Irritation Potential of the test product from Baseline to Post application
Time frame: Irritation Scoring at 30 minutes, and 24 hours, 168 hours post patch removal.
To evaluate the dermatological irritation potential of the test products by applying Patch Test Under Complete Occlusion for continuous 24 Hours exposure on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination)
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: At 30 minutes (on Day2) and 24 hours (on Day 3) post patch removal and up to 9 days from the Day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- 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, MBBS principal investigator
Medical Director
Questions about this trial
What is this clinical trial studying?
A study testing Peptide complexed HA Age Defying Gel with Vitamin C & Niacinamide, Peptide complexed HA Age Defying Gel with Natural Extracts and Peptide complexed HA Age Defying Gel with Vitamin C & Natural Extracts in people with Healthy, run by NovoBliss Research Pvt Ltd.
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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maheshvari N Patel, M.Pharma (91-9909013236, maheshvari@novobliss.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Irritation Potential of the test product from Baseline to Post application (time frame: Irritation Scoring at 30 minutes, and 24 hours, 168 hours post patch removal.). 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 14 Dec 2022; AzTrials last refreshed its copy on 28 Oct 2026.