| CTRI Number |
CTRI/2025/02/080244 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effectiveness and Safety of a Skincare Product for Reducing Acne |
|
Scientific Title of Study
|
To evaluate the in vivo safety and efficacy of Skin care formulation in terms of reduction in acne breakouts and redness on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-ZF02-XK-SR24; Version: 01; Dated: 13/01/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd.
Corporate Enclave, 2nd Floor,
B D Sawant Marg, Chakala,
Off western Express Highway,
Andheri (East), Mumbai – 400099. |
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd. |
| Address |
Corporate Enclave, 2nd Floor,
B D Sawant Marg, Chakala,
Off western Express Highway,
Andheri (East), Mumbai – 400099. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Pooja Yadav |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
poojayadav@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having mild to moderate acne on face or body/back(L70.9 - Acne, unspecified) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
D’ ACNE soap (S23DN008) (S24DN013) (S24DN008) |
The Product is applied to wash the face, back and body of subject once in a day at morning for the period of 28 days |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)Indian male and female subjects.
2)Healthy subjects
3)Skin is healthy on the studied anatomic unit
4)Having oily to mixed oily skin type.
5)Having mild to moderate acne on face or body/back.
6)Having visible pores.
7)Having white heads and black heads. |
|
| ExclusionCriteria |
| Details |
1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2. Having refused to give his/her assent by not signing the consent form and Informed consent form
3. Taking part in another study liable to interfere with this study
4. Being known diabetic case
5. Known asthma case
6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7. Being known thyroid case
8. Being epileptic.
9. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol)
10. Known case of hypersensitivity.
11. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
12. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in acne (live/occurring) breakouts and redness |
Baseline, Day 1, Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 21, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in pore size, sebum, white heads and blackheads |
Baseline, Day 1, Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 21, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
11/02/2025 |
| 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="3"
Days="0" |
|
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
|
PRIMARY OBJECTIVE: To evaluate the in-vivo safety and
efficacy of Skin care formulation in terms of reduction in acne
(live/occurring) breakouts and redness on healthy human subjects.
SECONDARY OBJECTIVE: To evaluate the in-vivo safety and
efficacy of a skin care formulation in terms of reduction in pore size, sebum,
white heads and blackheads on healthy human
The evaluation is performed using: Subject Self Evaluation
(SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological
Evaluation: Efficacy, Sebumetry, Illustrative Images of the whole face &
3/4th face under diffuse light
POPULATION: 36 Female and Male subjects will be selected for
the study (30 completed cases).
The subjects selected for this study are healthy males &
females, aged between 18-30 years of age having mild to moderate acne on face
or body/back and oily to mixed oily skin type, visible pores, white heads and
blackheads.
STUDY DURATION: 28 days following the first application of
the product. |