| CTRI Number |
CTRI/2024/01/061563 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the safety and efficacy of Skin care product for its non comedogenic effect |
|
Scientific Title of Study
|
A prospective, open-label, one arm study to evaluate the safety and efficacy of Efatop HYDRA GEL for its noncomedogenic effect in healthy male or female volunteers. |
| Trial Acronym |
Non-comedogenic |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/NCOM3/2023 Version Number: 1.0 Dated: 16-Oct-2023 |
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 |
Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| 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 |
Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka, India.
KARNATAKA
560058
India |
| Phone |
9880999297 |
| 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 |
Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka, India.
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| ERIS LIFESCIENCES LTD.
1st Floor, Shivarth Ambit, Opp. Janvi Bunglows,
Nr. Mann Party Plot, Sindhu Bhavan Road,
Ahmedabad-380054
|
|
|
Primary Sponsor
|
| Name |
ERIS LIFESCIENCES LTD. |
| Address |
1st Floor, Shivarth Ambit, Opp. Janvi Bunglows,
Nr. Mann Party Plot, Sindhu Bhavan Road,
Ahmedabad-380054
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
Shetty’s Hospital |
Plot no, 11 & 12, 12th F
Main Rd, Room no 2, Department of medicine Ground floor Kaveri Nagar, Bommanahalli,
Bengaluru, Karnataka 560068
Bangalore
KARNATAKA |
8065733349
drmadan1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shetty’s Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Efatop HYDRA GEL |
Dosage form: Semi Solid,
Administration: Topical
application, Direction for use: Apply on face twice a day |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy Indian male/female healthy volunteers aged between 18-55 years.
2.Willing to give Informed Consent Form.
3.Subjects with Clear to mild skin condition according to GAGS score 0 to 2.
4.Willing to complete the study assessments/questionnaires.
5.Willing to avoid usage of his/her own skin care products for at least one week before Commencement and during this study.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy or breast feeding.
2.Patients with pre-existing severe systemic disease necessitating long-term medication.
3.Patients with mild to severe Anaphylaxis reactions.
4.Evidence of significant uncontrolled co-morbid disease.
5.History of cancer, including solid tumours, hematologic malignancies and carcinoma in situ
6.Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
7.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
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To assess the safety and efficacy of skin care product for its non-comedogenic property.
Following parameters will be evaluated:
• Appearance of black heads through Videoscopy.
• Assessments of blocked pores through pore indicator test.
|
Day 0 to 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 to Day 30 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/01/2024 |
| Date of Study Completion (India) |
15/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
After the Ethics committee approval subjects will be asked to visit the site. Informed consent will be provided to the study volunteers, and after obtaining their consent, the subjects will be asked about their medical history and the Investigator or his/her designee will conduct a physical examination. Demographics and vital signs will be recorded. Subjects will be instructed to avoid using their own skin care products for at least one week before commencement of this study. Once the subjects are found eligible they will be provided with the IP and advised to use on a daily basis. The product efficacy is determined by performing the assessments like GAGS score, Pore Indicator Test and Videoscopy will be done on Visit 1, Visit 2 and Visit 3. Subjects will be advised to fill the feedback questionnaires on Visit 3. The responses obtained will be statistically analyzed at the end of the trial to assess the safety and efficacy of the product. |