| CTRI Number |
CTRI/2024/12/078726 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Non-comedogenicity Study] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate the safety and efficacy study of the test product. |
|
Scientific Title of Study
|
A Randomised, Evaluator-Blinded, Comedogenicity Study to Evaluate the Comedogenic Potential of Test Products in Healthy, Adult, Male and Female Subjects using Cyanoacrylate Follicular Biopsy Analysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240052-CL,Final1.0,14Mar24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India -
Gandhinagar
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, R and D Centre, East Block, 2nd floor, L.B.S. Road, Vikhroli (West), Mumbai- 400083, India |
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Cipla Ltd, R and D Centre, East Block, 2nd floor, L.B.S. Road, Vikhroli (West), Mumbai- 400083, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Pvt. Limited |
Clinical Trial Department NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
presence of prominent follicular orifices and the ability to form comedones on the upper part of the back |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Isopropyl myristate - Neat |
Mode of usage: 0.2 mL of test products will be dispensed via pipette/syringe directly in the centre Webril pad of the patches, will be applied immediately on the designated test site on the subjects upper back where prominent follicular orifices are present on the skin Dose: 0.2mL
Duration: 29 Days |
| Intervention |
Salicylic Acid –
Hydrating Facial Cleanser |
Marketed by: Cipla Limited
mode of usage: 0.2 mL of test products will be dispensed via pipette/syringe directly in the centre Webril pad of the patches, will be applied immediately on the designated test site on the subjects upper back where prominent follicular orifices are present on the skin
Dose: 0.2mL
Dosage Form: face Wash
Duration: 29 Days |
| Comparator Agent |
Untreated Site (0.9w/v normal saline solution) |
Mode of usage: 0.2 mL of products will be dispensed via pipette/syringe directly in the centre Webril pad of the patches, will be applied immediately on the designated test site on the subjects upper back where prominent follicular orifices are present on the skin Dose: 0.2mL
Duration: 29 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18-50 years (both inclusive) at the time of consent
2) Sex: Healthy male or healthy non-pregnant and non-lactating females.
3) Female of childbearing potential must have a negative urine pregnancy test performed on screening visit.
4) Subject is in good general health as determined by the Investigator on the basis of medical history.
5) Subject with presence of prominent follicular orifices and the ability to form comedones on the upper part of the back (shoulder area).
6) Subjects willing to maintain the test patches on designated application sites for consecutive 29 days (4 weeks).
7) The Subjects willing to give written informed consent and willing to follow study procedure.
8) Subject are willing and able to make all evaluation visits and follow the protocol instructions. |
|
| ExclusionCriteria |
| Details |
1)Subjects who do not have presence of prominent follicular orifices and not have ability to form comedones on the upper part of back.
2)Subject has damaged skin in or around application sites, tattoos, scars, excessive hair, moles, burn marks/ scars or other disfiguration of the application sites.
3)Medical past and present history of significant dermatologic diseases or conditions, such as atopy, psoriasis, eczema, atopic dermatitis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.
4)History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the patch application site.
5)Presence of open sores or other skin abnormalities at the application site.
6)History of skin allergy to adhesive tapes, adhesive materials or with other medications, cosmetics, toiletries, fragrances, topical skin products or other dermatological products.
7)Subject have used an active topical or systemic acne medication in the previous two weeks.
8)Have significant diseases or clinically significant abnormal findings during screening (brief medical history, abbreviated physical examination, and laboratory evaluations).
9)Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
10)History of presence of bronchial asthma.
11)Uses of any topical products (except soap) at application site prior to 24 hours of patch application.
12)Routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamines medications, antibiotics, retinoids, or exfoliative agents (steroid nose drops and/or eye drops are permitted) within 72 hrs prior to patch application.
13)Subject has a 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.
14)Show evidence of dermatological diseases or have a history of sun hypersensitivity and photosensitive dermatoses.
15)Have active acne vulgaris over the upper back.
16)Subject with positive hepatitis-self reported (subtypes B).
17)Subject with known history of positive HIV.
18)Pregnant or lactating females.
19)Participation in any clinical study or transdermal/topical patch study with active drug OR any patch study at the same application site within the last four weeks prior to patch application.
20)Be an employee of the sponsor or the site conducting the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine comedogenicity of the test product - if score is 1-3 in one or more subjects. |
Baseline before application of the test product to Day 01 to visit 14 (Day 29).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the degree of microcomedone of test products. |
Baseline before application of the test product to
after application at Day 01 to visit 14 (Day 29). |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized, evaluator-blinded, comedogenicity study to evaluate the comedogenic potential of the test products in human healthy, adult, male and female subjects by patch test. The potential subjects with prominent follicular orifices with ability to form comedones will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects. The subject will be instructed to visit the facility as per the below visits: • Visit 01 (Within 15 days): Screening • Visit 02 (Day 01): Enrolment, Randomization, 1st Application • Visit 03 to Visit 13 (Day 03 ±1 Day to Day 26 ±1 Day): Patch application, patch removal, and irritation scoring • Visit 14 (Day 29 ± 1 Day): End of the study. |