| CTRI Number |
CTRI/2024/10/075272 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study to test effectiveness of test product in reducing skin spots,acne and other skin problems. |
|
Scientific Title of Study
|
A clinical study to evaluate the
anti-blemish efficacy of the test
product. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/PUAB/2024-01 version 1.0 dated 26 Sep 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
Department of Skin Sciences,
324 Second Floor,
1st Main Road, Cambridge Layout
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917243 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
Department of Skin Sciences,
324 Second Floor,
1st Main Road, Cambridge Layout
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917243 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
Department of Skin Sciences,
324 Second Floor,
1st Main Road, Cambridge Layout
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917243 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Antonio Puig S.A.
Plaza Europa 46-48 LHospitalet
de Llobregat, Barcelona
08902 Cataluña
Spain |
|
|
Primary Sponsor
|
| Name |
Antonio Puig S A Plaza |
| Address |
Europa 46-48 LHospitalet de Llobregat Barcelona 08902 Cataluña Spain |
| Type of Sponsor |
Other [Cosmetics] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd. |
Department of Skin Sciences
324 Second Floor
1st Main Road, Cambridge Layout
Ulsoor
Bangalore
KARNATAKA |
08040917243
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independant Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Face oil |
Gently apply 4-5 drops of face oil dot wise twice a day (morning and evening) after washing the face. The product should be gently massaged using the fingertips in the upward direction until the oil is fully absorbed into the skin. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Female subjects in general good health.
2 Subjects in the age group 18-35 years both ages inclusive
3 Subjects with blemishes like spots, pigmentation blackheads, PIH, acne, unevenness, scars on the face
4 Subjects willing to give written informed consent and willing to abide by and comply with the study protocol
5 Subjects who have not participated in a similar investigation in past two weeks.
6 Subjects willing to refrain from using any other product or home remedies that can impact the skin.
7 Subjects who agree not to participate in any other clinical study during participation in the current study.
|
|
| ExclusionCriteria |
| Details |
1 A known history or present condition of an allergic response/hypersensitivity to any cosmetic or skin pharmaceutical product.
2 Subject having active skin diseases like active atopic dermatitis, pigmented contact dermatitis or other cutaneous manifestation, which will interfere with the assessment.
3 Female subjects who are pregnant or lactating (Self declared).
4 Subjects who have undergone facial treatments in past 4 weeks.
5 Subjects on oral medications like topical or systemic corticosteroids, anti fungal, or antibiotics, or any prolonged use of non steroidal anti inflammatory, or anti histaminic within 2 weeks prior to the study, undergoing any chemical treatment-facial or bleach or waxing or which will compromise the study.
6 Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, thyroid, hepatitis, severe anemia, serious disorder of the heart and respiratory apparatus or any other serious medical illness.
7 Employees of MSCR or the sponsor.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in skin blemishes (spots, pigmentation, blackheads, PIH, acne, unevenness, scars etc.) |
baseline, Week 2, Week 4, Week 8, Week 12. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Reduction in sebum (sebum control) production after test product usage analyzed by Sebumeter
2 Improvement in facial gloss and radiance after test product usage using Glossymeter.
3 Improvement in the skin barrier function after test product usage analyzed by Tewameter
4 Improvement in skin color after test product usage using Spectrophotometer.
5 Improvement in the skin hydration after test product usage analyzed by Corneometer
6 Improvement in the skin firmness after test product usage analysed by Cutometer
7 Evaluation of Safety and tolerability of the test product |
baseline, Week 2, Week 4, Week 8, Week 12. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/10/2024 |
| 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
|
This study is designed to assess the efficacy of a test product in reducing blemishes in a full face single arm study design. The study will span over 12 weeks where dermatological and instrumental assessments to evaluate change in appearance of skin blemishes, sebum content, glow and radiance, skin colour, safety and tolerability of the test product will be done. |