| CTRI Number |
CTRI/2021/04/032787 [Registered on: 13/04/2021] Trial Registered Prospectively |
| Last Modified On: |
21/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Safety test |
| Study Design |
Other |
|
Public Title of Study
|
Safety study of Acne Recovery Lotion |
|
Scientific Title of Study
|
Study of Safety of ACNE RECOVERY LOTION by patch test as per BIS 4011 : 2018 ( Third Revision ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir V Medhekar |
| Designation |
Principle Investigator |
| Affiliation |
Sanity Lifesciences Pvt.. Ltd. |
| Address |
Dr. Joshi’s Clinic Clinic no. 2 212, Kamal Kunj, Behind Ruia College, Lady Jahangir Road, Matunga, Mumbai – 400019
India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820321430 |
| Fax |
|
| Email |
sudhir.medhekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir V Medhekar |
| Designation |
Principle Investigator |
| Affiliation |
Sanity Lifesciences Pvt.. Ltd. |
| Address |
Dr. Joshi’s Clinic Clinic no. 2 212, Kamal Kunj, Behind Ruia College, Lady Jahangir Road, Matunga, Mumbai – 400019
India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820321430 |
| Fax |
|
| Email |
sudhir.medhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAMEER SHINDE |
| Designation |
Director |
| Affiliation |
Sanity Lifesciences Pvt. Ltd |
| Address |
9A/704, Powai Cosmopolitan CHS, Ram Baug, A. S. Marg, Powai, Mumbai - 400076
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9323726642 |
| Fax |
|
| Email |
sameer@sanitylifesciences.com |
|
|
Source of Monetary or Material Support
|
| NIKKOL GROUP COSMOS TECHNICAL CENTER CO LTD |
|
|
Primary Sponsor
|
| Name |
NIKKOL GROUP COSMOS TECHNICAL CENTER CO LTD |
| Address |
3-24-3 Hasune, Itabashi-ku,
Tokyo, Japan - 174-0046 |
| Type of Sponsor |
Other [Cosmetic manufacturers] |
|
|
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 Sudhir Medhekar |
Dr. Joshis Clinic |
Clinic No. 2, 212, Kamal Kunj, Behind Ruia College, Lady Jahangir Road, Matunga, Mumbai – 400019
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9820321430
sudhir.medhekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SANITY LIFESCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No disease, healthy, skin type III to V. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Phototype III to V.
Healthy skin on test area.
having signed a consent form
able to read and write
valid id prrof.
urine test negative for women. |
|
| ExclusionCriteria |
| Details |
1.Pregnant/nursing mothers.
2. Scars, excessive terminal hair or tattoo on the studied area.
3. Henna tattoo anywhere on the body (in case of studies involving hair dyes).
4. Dermatological infection/pathology on the level of studied area.
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
7. Chronic illness which may influence the outcome of the study.
8. Subjects 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. Subjects in an exclusion period or participating in another food or cosmetic or therapeutic trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of skin irritation potential ( Occurence of Erythema and Oedema ) w.r.t. Investigational Products at 4th day. |
4th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Check Contact Hypersensitivity as per BIS 4011 : 2018 directives |
at 4th day |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
31/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to assess the irritancy of cosmetic products on human skin.
The protocol of this study is as per BIS guidelines, IS 4011 : 2018 , where 24 adult volunteers ( 12 male and 12 female ) participate in the study after meeting the Inclusion and Exclusion criteria.
Require quantity of Investigational Products along with positive & negative control taken on Finn chambers and same will apply on the upper back of volunteers. For Soaps, the patch type is occluded and for Deodorants, patch type is Semi-occluded.
Finn chambers will be removed after 24 hours of patch application and reading will be taken after 24 hours of patch removal.
As per BIS directives, readings in term of erythema and oedema noted by PI in accordance with Draize scale.
The combined mean score upto 2.0 / 8.0 will mean that product is non-irritating. |