| CTRI Number |
CTRI/2026/02/104183 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cumulative Irritation Patch Test of Jolune MBG-179 and MBG-180 |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Cumulative Irritation Patch Test of Jolune MBG-179 and MBG-180 on Healthy Human volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT1255 Protocol Version 1.0 dated 23 Jan 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| Jolune, Dallas, Texas 75081 |
|
|
Primary Sponsor
|
| Name |
Jolune |
| Address |
Dallas, Texas 75081 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 Robin Chugh |
CCFT laboratories |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road- 250005
Meerut
UTTAR PRADESH |
09027285265
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Finn chamber |
Each patch contains 40 micrograms/microliter of 1.MBG-179 2. MBG-180 3. Negative control0.9% NaCl, 4. Positive Control- 1% SLS Route of Administration: Topical Frequency: Once Duration:14 Days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female, between 18 and 65 years of age, inclusive.
2. In good general health as determined by medical history and physical examination.
3. Willing and able to provide written informed consent prior to any study-related procedures.
4. Willing and able to comply with all study procedures and visit schedules.
5. Skin on the upper back must be free of acne, sunburn, scars, tattoos, moles, or any other condition that could interfere with patch application or skin evaluation.
6. Females of childbearing potential (FOCP) must have a negative urine pregnancy test at screening and agree to use a medically acceptable method of contraception throughout the study. |
|
| ExclusionCriteria |
| Details |
1. History of or active dermatological condition (e.g., eczema, psoriasis, dermatitis) on the back or that could be exacerbated by the study.
2. Known allergy or sensitivity to cosmetics, topical drugs, medical adhesives (tapes), or any of the test material components, including SLS.
3. Use of systemic or topical corticosteroids, retinoids, or immunosuppressants within 4 weeks prior to Day 0.
4. Application of any topical product (including moisturizers) to the back within 24 hours prior to Day 0.
5. Excessive sun exposure or use of tanning beds on the back within 2 weeks prior to Day 0.
6. Currently pregnant, planning to become pregnant, or breastfeeding.
7. Participation in any other clinical trial involving an investigational drug or device within 30 days prior to Day 0.
8. Any condition which, in the opinion of the Principal Investigator, would place the subject at undue risk or interfere with the interpretation of the study results.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Skin Irritation Score-erythema & oedema |
Day1, Day3, Day5, Day8, Day10 and Day12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="16" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a single-center, evaluator-blinded, randomized, intra-individual controlled study. Each subject will serve as their own control. Three test sites will be delineated on the upper back (scapular region) of each subject. The location of the three test materials , positive control, negative control) will be randomized for each subject. A new set of patches will then be applied to the exact same sites. This procedure will be repeated for 14 days 3 times a week.
Study Duration: The total study participation for each subject will be approximately 16 days. This includes a Screening Visit, a 14-day treatment period (Day 1 to Day 14), and a Final Follow-up Visit.
Guideline Followed: IS10993 PART 23
30 healthy male and female volunteers aged 18 to 65 years
Test Product : 1. MBG-179 |