| CTRI Number |
CTRI/2025/01/078929 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[cosmetic product for efficacy and safety evalution]] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anti acne efficacy study in healthy male and female subjects |
|
Scientific Title of Study
|
A monocentric open label prospective clinical study to assess the anti acne efficacy of the Anti pimple Face Oil in healthy adult human male and female subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
9871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
9871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
9871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
| Eliea Wellness Private Limited |
|
|
Primary Sponsor
|
| Name |
Eliea Wellness Private Limited |
| Address |
House no: 8, BR Nagar, Noonmati, Guwahati-781022 India. |
| Type of Sponsor |
Other [Cosmetic manufacturer] |
|
|
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 Karishma Kapoor |
Auriga Research Private Limited |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI |
9871953143
karishma.kapoor@aurigaresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild to Moderate Acne |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti Pimple Face Oil (B. No- BO242163) |
Subjects will wash their hands properly before application of the product. Before every application the subject will wash their face with the provided neutral cleanser and pat dry the entire face. Two drops of the test product (Anti pimple Face Oil) will be applied on the facial acne and gently massage till it gets absorbed. The product will be applied twice daily for 3 days and 20 days for Group A and Group B respectively as per the treatment Regimen groups with approximately 8-10 hrs gap between application. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy male & female subjects in the age group of 18-45 years (both age inclusive)
Subject is having valid proof of identity and age
Subject is having apparently healthy skin on test area
Subjects must have a facial acne score of 1to 2 (For Group A) that will be clinically determined to be mild and a score of 2 to 3 (Group B) clinically determined to be clinically to be mild to moderate.
Subjects having 1- 3 inflammatory active lesions for (Group A) and 3-10 inflammatory active lesions (For Group B).
No treatment for acne/facial in the past 1 month.
Subjects willing to give voluntary written informed consent.
Subjects willing to come for regular follow up visits
Subjects ready to follow instructions during the study period
Subjects without any open wounds, cuts, abrasions, irritation symptoms on test area.
Subject willing to perform UPT (for females only).
|
|
| ExclusionCriteria |
| Details |
Subjects with Known hypersensitivity to any of the study products or constituents
Subjects who is using any oral or topical prescription or over-the-counter (OTC) acne treatments (and topical retinoids) within the past 30 days
Dark spots and post acne scars on the test area.
Subjects with any kind of skin allergy, antecedents or cutaneous disease or any significant pathology in the test area which may influence the study results.
Subjects having topical or systemic treatment in last month prior to participation in the study and during the study that could interfere with the study treatments/ assessments
Subject is Pregnant or Lactating
Subject with any significant medical condition that would interfere with the participation in the trial
Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation
Subject is having Scars, excessive terminal hair or tattoos on the test area.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visible reduction in acne appearance at Day 3 (For Group A) & at Day 20 (For Group B)
Notable reduction in the lesion count, specifically in the number of papules and pustules
Assessment of lesion size, skin smoothness, overall redness of inflammatory lesions, overall size of inflammatory lesions, comedogenic potential of the test product.
Percentage of subjects who achieved full relief from facial acne at Day 3 (For Group A) & at Day 20 (For Group B).
|
Group A Day 0 Day 1 Day 3
Group B Day 0 Day 10 Day 20 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Safety & Tolerability of the investigational product during the entire study duration of 3 Days (For Group A) & 20 Days (For Group B) |
Group A Day 0 Day 1 Day 3
Group B Day 0 Day 10 Day 20 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
28/01/2025 |
| 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="0"
Days="20" |
|
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
|
A
monocentric, open-label, prospective clinical study. Twenty-four healthy adult
male & female subjects in the age group of 18 to 45
years will be selected according to inclusion and
exclusion criteria & having mild to
moderate acne. The objective of this prospective,
open-label, single-centre study is to evaluate the efficacy and tolerance of
twice daily application for 3 days (For Group A) & 20 days (For Group B) of
Anti pimple Face Oil on healthy adult male & female subjects.
This study will be conducted over a
treatment period of 3 days (For Group A) and 20 days (For Group B) as per the
treatment regimen groups. The dermatological evaluation and subject self-evaluation
will be performed at the test site
at Day 0 (Baseline
before product evaluation),
Day 1, Day 3 for Group A and Day 0 (Baseline
before product evaluation), Day 10 and Day 20 for Group B.
Test site images will also be taken
at Baseline (Day 0) & Day 3 for Group A and at Baseline (Day 0) and Day 20
for Group B. Subject feedback will be taken at Day 3 and Day 20 for Group A and
Group B respectively. BO International is the manufacturer for the Anti pimple
Face Oil for Eliea Wellness.
|