| CTRI Number |
CTRI/2022/09/045553 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect and safety of an Anti-acne cream |
|
Scientific Title of Study
|
Evaluation of the efficacy and in use tolerance of a Product, CLEARICA®ANTI-ACNE CREAM, in men and women. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/056/0722/STU Version No.:1 of 26th August |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
4th floor, B wing, Modi House, C-10, Dalia Industrial Estate,
New Link Road, Andheri (W),
Mumbai
MAHARASHTRA
400 058
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Chidambara N |
| Designation |
Manager-Operations |
| Affiliation |
PhytoMyco Research Pvt. Ltd. |
| Address |
MF-11, Yadavagiri Industrial Estate
Mysore
KARNATAKA
570020
India |
| Phone |
|
| Fax |
|
| Email |
chidambara@phytomyco.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Chidambara N |
| Designation |
Manager-Operations |
| Affiliation |
PhytoMyco Research Pvt. Ltd. |
| Address |
MF-11, Yadavagiri Industrial Estate
Mysore
KARNATAKA
570020
India |
| Phone |
|
| Fax |
|
| Email |
chidambara@phytomyco.in |
|
|
Source of Monetary or Material Support
|
| PhytoMyco Research Pvt. Ltd. MF-11, Yadavagiri Industrial Estate, Mysore-570 020, Karnataka |
|
|
Primary Sponsor
|
| Name |
PhytoMyco Research Pvt Ltd |
| Address |
MF-11, Yadavagiri Industrial Estate,
Mysore-570 020, Karnataka, INDIA
|
| 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 Rajiv Joshi |
C.L.A.I.M.S. Pvt. Ltd. |
4th floor, B wing, Modi House, C-10, Dalia Industrial Estate,
New Link Road, Andheri (W)
Mumbai
MAHARASHTRA |
02266758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indepedent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers suffering from acne. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CLEARICA®ANTI-ACNE CREAM |
Face will be rinsed with water. Approximately 0.5 g of anti-acne cream.(visually, this is the size of a green pea)will be applied to each side of the face. Process will be repeated twice a day morning after bath and night before bedtime.
|
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and women between 16 and 30 years of age (approximately equal number).
2. Having mild to moderate active acne or Non-cystic acne.
3. Not on any treatment for acne.
4. Accepting not to use products with the same end benefit during the entire study duration.
5. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
6. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy by history and lactating women.
2. Premenstrual women and women on oral contraceptives.
3. Skin allergy antecedents or atopic subject.
4. Hypersensitivity to any cosmetic product, raw material.
5. PCOD, hirsutism, any hormonal issues etc by history or clinical examination.
6. For whom the Investigator considers that he/she will not be compliant with study procedures.
7. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
8. Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
9. Participant in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Acne lesions and redness by Clinical evaluation, Instrumentation and Self evaluation. |
Day 0, 72 hours, Day 7, Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of tolerance of the test product |
Day 0, 72 hours, Day 7, Day 21 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/09/2022 |
| Date of Study Completion (India) |
01/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Acne vulgaris (commonly called acne) is a common human skin problem, characterized by areas of skin with multiple non inflammatory follicular papules or comedones and by inflammatory papules, pustules, and nodules in its more severe forms. Propionibacterium acnes is the principal organism associated with inflammatory acne lesions. Acne is caused by the combination of too much sebum and a buildup of dead skin cells. Acne vulgaris mostly affects the areas of skin with the densest population of sebaceous follicles; these areas include the face, the upper part of the chest, and the back. Acne occurs most commonly during adolescence, affecting more than 96% of teenagers, and frequently continues into adulthood. Acne can have a significant physical, emotional, and social impact on an individual. Today there are many agents being used for relief from acne. The product, CLEARICA®ANTI-ACNE CREAM, is claimed to have anti acne effect, and this will be evaluated during the course of this study
Result: The study was completed with 33 complete cases and no adverse events. |