| CTRI Number |
CTRI/2024/10/075997 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the potential allergies
to Seriderm (TM) Non-adherent absorbent wound dressing device of Serigen Mediproducts Pvt. Ltd. by
conducting Skin Prick Test in healthy adult human subjects |
|
Scientific Title of Study
|
An Open Label, Non-randomized, Single-Centre, Single Arm Study to evaluate the potential allergies
to Seridermâ„¢ Non-adherent absorbent wound dressing device of Serigen Mediproducts Pvt. Ltd. by
conducting Skin Prick Test in healthy adult human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Serigen Mediproducts Pvt. Ltd., Plot 39, Electronic Co-Op Estate, Parvati Payatha, Pune, India-411009 |
|
|
Primary Sponsor
|
| Name |
Serigen Mediproducts Pvt. Ltd. |
| Address |
Plot 39, Electronic Co-Op Estate, Parvati Payatha, Pune, 411009 |
| Type of Sponsor |
Other [Medical equipment manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Tejo Swaroop Kumar |
Noah Therapeutics Private Limited |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad, Telangana -500018 (India)
Phone No.: +91 9958509329
Hyderabad
TELANGANA |
09958509329
tejoswaroopd@noahtherapeutics.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHOS INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intervention product-Seriderm(TM) Non-adherent absorbent wound dressing device. Positive control-Histamine solution Negative control-Normal saline solution. |
This study aims to evaluate allergic reactions of the interventional product by performing skin prick test. The prick sites will be examined at 15 minutes, 6.00 hours and 24.00 hours after prick for assessing allergic reactions. Subject will be in housed for 24.00 hours after prick.
This product is already marketed in india from 2021. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult, human volunteers, of either sex, aged above 18 years.
2.Completed written informed consent and receive a copy of their executed ICD.
3. Volunteers must be capable of understanding.
4. Body mass index of  18.50 kg/m2 and  30.00 kg/m2 (inclusive of both) and weight
 50 kgs for male subjects and  45 kgs for female subjects.
5. Volunteers with no known allergic reactions
6. Volunteers willing to give written informed consent and adhere to all the requirements of the
protocol |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or lactation
2. Inadequate or non-existent contraception (women of child bearing potential only).
3. A current skin disease of any type apart from mild facial acne (e.g. eczema, psoriasis).
4. Volunteers known, or thought to be hypersensitivity to test product.
5. Current use or history of repeated use of recreational drugs.
6. Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive,
hematological, neurological, locomotor or psychiatric disease.
7.0Participation in a Human Repeat Insult Patch Test (HRIPT), Skin Prick Test (SPT) or followup work within the last month. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the allergic reactions of Seridermâ„¢ Non-adherent absorbent
wound dressing device by skin prick test. |
The outcome will be assessed at 15 minutes, 6 hours & 24 hours after skin prick |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitoring of adverse events and change in vital signs. |
Through out the study. |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2024 |
| Date of Study Completion (India) |
29/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study was initiated on 28 Oct 2024. Total of 25 subjects were
enrolled in the study. Study was completed on 29 Oct 2024. Total of 25 subjects
completed the study. Overall, the data
indicate that the Seriderm® non-adherent
absorbent wound dressing did not have significant allergic reactions after
skin prick test over the course of the study. The negative control did not
produce the same reaction as the positive control. The positive control
exhibited a significantly stronger reaction compared to both the negative
control and the test product. No statistically significant difference was observed
between the reactions of the negative control and the test product. The
negative control sites showed a wheal size of "0 mm" in all subjects,
while the positive control sites had an average wheal size of "5.480 mm at
15 minutes assessment after prick, 2.200 mm at 6 hours assessment after prick
and 0.360 mm at 24 hours assessment after prick". Both controls confirm
the sensitivity and specificity of the test. No AEs/SAEs were reported in the study. All the
subjects vital signs were within normal ranges throuhout the study.
|