| CTRI Number |
CTRI/2025/07/090443 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the Safety and Non-Comedogenic Effect of a Skin Care Product in Healthy Volunteers. |
|
Scientific Title of Study
|
A Prospective, open-label, one arm study to evaluate the safety and efficacy of Skin care product for its non-comedogenic effect in healthy male or female volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/NCOM/2025 Version: 1.0, Date: 16th April 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd. |
| Address |
Radiant Research Services Pvt Ltd.
Plot No:99/A, 8th Main Road, III Phase,
Peenya Industrial Area, Bengaluru, 560058,
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd. |
| Address |
Radiant Research Services Pvt Ltd..
Plot No:99/A, 8th Main Road, III Phase,
Peenya Industrial Area, Bengaluru, 560058,
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd. |
| Address |
Radiant Research Services Pvt Ltd.
Plot No:99/A, 8th Main Road, III Phase,
Peenya Industrial Area, Bengaluru, 560058,
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Anil kumar, Director Neeta life sciences Pvt. Ltd,
Plot no 379, Road No 10, Jubilee Hills,
Hyderabad, Telangana, 500033 |
|
|
Primary Sponsor
|
| Name |
Neeta life sciences Pvt Ltd |
| Address |
Plot no 379, Road No 10, Jubilee Hills, Hyderabad, Telangana, 500033 |
| Type of Sponsor |
Other [[Cosmetic 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 Madan Mohan N T |
Sri Venkateshwara Hospital |
Department of Dermatology Sky heights, Site No1/2, Sarjapura, Attibele Mail Road
Indelebele Village, Bengaluru, Karnataka 562107
Bangalore
KARNATAKA |
9845074316
madanmohan1869@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Acne Participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
NA |
| Intervention |
SHRUMEI Dark Spot Corrector serum |
Take small amount of cream and gently massage it on the skin
in the morning and in the evening after washing the face and patting it dry, Duration 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
• Healthy Indian male and female healthy volunteers aged between 18-55 years.
• Willing to give Informed Consent Form.
Subjects with Clear to mild skin condition according to GAGS score 0 to 18.
• Willing to complete the study assessments questionnaires.
• Willing to avoid usage of his or her own moisturizers and face Cream for at least one week before Commencement and during this study. |
|
| ExclusionCriteria |
| Details |
Pregnancy or breast feeding.
• Patients with pre existing severe systemic disease necessitating long-term medication.
• Patients with mild to severe Anaphylaxis reactions.
• Evidence of significant uncontrolled co-morbid disease.
• History of cancer, including solid tumors, hematologic
malignancies and carcinoma in situ
• Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
• Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcomes:
1.Percentage evaluation in Global Acne Grading System (GAGS Score)
2.Evaluation of blocked pores through pore indicator test.
3.Visual observation of Comedones through Videoscopy.
4.Evaluation of cutaneous melanin by Mexameter. |
Day 0, Day 15, Day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire. |
Day 0, Day 15, Day 30. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| Date of Study Completion (India) |
25/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
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
|
Comedones are the skin-colored, small bumps (papules) frequently found on the forehead and chin of those with acne. A single lesion is a comedon. There are different types of comedones as follows, Open comedones are blackheads; black because of surface pigment (melanin), rather than dirt. Closed comedones are whiteheads; the follicle is completely blocked. Microcomedones are so small that they are not visible to the naked eye. Macrocomedones are facial closed comedones that are larger than 2–3 mm in diameter. A giant comedo is a type of cyst in which there is a clear blackhead-like opening in the skin. Solar comedones are found on the cheeks and chin of older people, and are thought to be due to sun damage |