| CTRI Number |
CTRI/2026/01/100866 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Mformulae Acne Barrier Ritual and Mformulae Calming Matte on healthy participants with dry and sensitive skin. |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Mformulae Acne Barrier Ritual and Mformulae Calming Matte for skin barrier repair in healthy participants with dry and sensitive skin. - An open label, non-comparative, interventional, prospective, clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Mformulae/BRCM/MJ-COS/CT-1/2025, Version 1.0, 27th Nov 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaam Agarwal |
| Designation |
Consultant Dermatologist |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt Ltd. Department of Clinical Research, OPD 1, Office E-203, Jaymala Business Court, Takle Nagar Manjri BK. Hadapsar Pune
Pune
MAHARASHTRA
412307
India |
| Phone |
9422026123 |
| Fax |
|
| Email |
drshaam@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd |
| Address |
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A, B, C, Jaswanti Allied Business Centre,
Ramchandra Lane Extension,
Kanchpada, Malad West, Mumbai
Pune
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd |
| Address |
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A, B, C, Jaswanti Allied Business Centre,
Ramchandra Lane Extension,
Kanchpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MJ-Cos Sciences Private Limited
Flat No. 5 IInd Floor, Plot No.15
CTS NO. 12491/9 Santeknath Housing,
Chhatrapati Sambhaji Nagar (Aurangabad),
Maharashtra, India 431001
|
|
|
Primary Sponsor
|
| Name |
MJ-Cos Sciences Private Limited |
| Address |
Flat No. 5 IInd Floor, Plot No.15
CTS NO. 12491/9 Santeknath Housing,
Chhatrapati Sambhaji Nagar (Aurangabad),
Maharashtra, India 431001
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
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 Shaam Agarwal |
Target Institute of Medical Education and Research Pvt Ltd. |
Department of Clinical Research, second floor, OPD No. 1, Office E-203, Jaymala Business Court, Takle Nagar Manjri BK. Hadapsar Pune-412307.
Pune
MAHARASHTRA |
9422026123
drshaam@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kusum Independent Ethics Committee, Hadapsar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L853||Xerosis cutis, (2) ICD-10 Condition: R21||Rash and other nonspecific skin eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mformulae Calming Matte and Mformulae Acne Barrier Ritual |
Subjects will be asked to apply Mformulae Calming Matte all over the face during day time(after bath) and Mformulae Acne Barrier Ritual for night routine (at least 30 minutes before going to bed) every day for a period of 30 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having mild to moderate skin dryness and any one of the skin conditions i.e. irritation, erythema, swelling, and itching (assessed using clinical grading score) due to skin currently on retinoid treatment, reactive rosacea-prone (currently calm skin), atopy-prone (currently calm skin but has a history of easy flaring), skin currently on benzoyl peroxide treatment for acne, acne-prone/oily with dehydrated combination skin, post-procedure skin (7 to 14 days after chemical peel or microneedling treatment), post-procedure laser skin treatment (5 to 7 days after the treatment).
2. Willing to comply with all requirements of the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
2. Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.
3. Subjects with intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
4. Subjects who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs. Moisturizing cream, lotion or oil within 21 days before entering the trial
5. Subjects on any other investigational products within 1 month prior to randomization
6. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure
7. Pregnant and lactating women
8. Known hypersensitivity to any of the ingredients of Mformulae Acne Barrier Ritual and Mformulae Calming Matte
9. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in investigator-assessed skin irritation, erythema, swelling, and itching
2. Change in skin cutaneous moisturization or skin dryness
|
Baseline visit, 5 mins after application of product, day 15 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Change in water content or hydration of the skin surface as assessed using Corneometer
2 Change in Trans epidermal water loss as assessed using Tewameter
3 Change in calming or soothing effect
4 Acceptance of scent or aroma as assessed using graded scale
5 Changes in blemishes on skin
6 Skin patch test using Dermal Response Score.
7 Difference in number of comedones i.e. blackheads and whiteheads on the face and body
8 Assessment of ability of Mformulae Acne Barrier Ritual and Mformulae Calming Matte to absorb into the skin
9 Assessment of oily or greasy appearance of skin after application of study products
10 Assessment of feeling of oil on skin
11 Global assessment of overall change by participants and physician
12 Assessment of post treatment tolerability of study drug by participants and physician.
13 Assessment of adverse events, adverse drug reactions including vitals
|
Baseline visit, 5 mins after application of product, day 15 and day 30 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is an open label, non-comparative, interventional,
prospective, clinical study to evaluate efficacy and safety of Mformulae
Acne Barrier Ritual and Mformulae Calming Matte for skin barrier repair in
healthy participants with dry and sensitive skin. The study will be conducted
in India at one centre. Subjects
will be asked to apply
Mformulae Calming Matte all over the face during day time (after bath) and
Mformulae Acne Barrier Ritual for night routine (at least 30 minutes before
going to bed) every day for a period of 30 days. The primary objectives of the
study will be to assess change in investigator-assessed skin irritation,
erythema, swelling, and itching and change in skin cutaneous
moisturization/skin dryness. The secondary objectives of the study will be to
assess change in
water content or hydration of the skin surface as assessed using Corneometer, change
in Trans epidermal water loss (TEWL) as assessed using Tewameter, change in
calming or soothing effect, acceptance of scent or aroma as assessed using
graded scale, changes in blemishes on skin, skin patch test using Dermal
Response Score, difference in number of comedones (blackheads and whiteheads)
on the face and body, ability of Mformulae Acne Barrier Ritual and Mformulae
Calming Matte to absorb into the skin, oily or greasy appearance of skin after
application of study products, feeling of oil on skin, global assessment of
overall change by participants and physician, post treatment tolerability of
study drug by participants and physician and adverse events/adverse drug
reactions including vitals on baseline visit, 5 mins after application of
product, day 15 and day 30 |