| CTRI Number |
CTRI/2023/12/060478 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
13/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of a novel test product for treatment of epidermal melasma |
|
Scientific Title of Study
|
Evaluation of efficacy, safety, and tolerance of a liposomal based cocktail of topical depigmenting agents for treatment of epidermal melasma |
| 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 Shilpa Kanathur |
| Designation |
Associate Professor & Head |
| Affiliation |
Bangalore Medical College & Research Institute, Bengaluru |
| Address |
Room No. 53, OPD B Block, Department of Dermatology, Venereology & Leprosy, Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI), Bengaluru, Karnataka, India.
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
shilpakvinod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prashanti Patil |
| Designation |
Chief Scientific Officer |
| Affiliation |
SHNI Ventures LLP |
| Address |
No.15-2, Gidadakonenahalli, Herohalli, Yeshwanthpur, Bengaluru,
Bengaluru Urban
Bangalore
KARNATAKA
560091
India |
| Phone |
9513704833 |
| Fax |
|
| Email |
drprashantipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashanti Patil |
| Designation |
Chief Scientific Officer |
| Affiliation |
SHNI Ventures LLP |
| Address |
No.15-2, Gidadakonenahalli, Herohalli, Yeshwanthpur, Bengaluru,
Bengaluru Urban
Bangalore
KARNATAKA
560091
India |
| Phone |
9513704833 |
| Fax |
|
| Email |
drprashantipatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHNI Ventures LLP,
No. 15/2, Gidadakonenahalli, Herohalli, Yeshwantpur, Bengaluru, Karnataka 560091 |
|
|
Primary Sponsor
|
| Name |
SHNI Ventures LLP |
| Address |
No.15/2, Gidadakonenahalli, Herohalli, Yeshwanthpur, Bengaluru,
Bengaluru Urban, Karnataka, 560091 |
| Type of Sponsor |
Other [FMCG (Fast Moving Consumer Goods)] |
|
|
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 Shilpa Kanathur |
Bangalore Medical College & Research Institute |
No. 53, Department of Dermatology, Venereology and Leprosy, Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI), Bengaluru, Karnataka, India.
Bangalore
KARNATAKA |
9513704833
shilpakvinod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College & Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L814||Other melanin hyperpigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SHNI Cream |
A thin coat (pea sized) of SHNI Cream to be applied topically to full face once a day for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1)Female and male patients, from 18-45 years of age with epidermal melasma.
2)Subjects with mild to moderate epidermal melasma.
3)Participants who can provide a written informed consent and photo consent form.
4)Participants who are willing to follow up for four visits over a period of 12 weeks.
5)Participants who are able and willing to follow all the study procedures including abstinence from usage of any OTC product related to face applications.
6)Participants who are willing to be clinically photographed as per protocol. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1)Patient who is not willing to participate in the study.
2)Patients who are using other pigment reduction creams (except sunscreen and a base moisturiser).
3)Subjects with other dermatological disorder of the face that may interfere with the study evaluation (Acne, DPN, Seborrheic melanosis)
4)Subjects with known hypersensitivity to any of the study compunds or constituents.
5)Subjects who are expected to be exposed to the triggering factors (excessive sun exposure, UVB photo therapy, use of OCPs).
6)Patient who has received facial procedures like dermabrasion, chemical peels, or laser procedures within the last 1 month.
7)Any patient as per investigator’s opinion is unfit for participation in the study.
8)Pregnant / lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate improvement in modified Melasma Area and Severity Index (mMASI) score. |
Month 0, Month 1, Month 2, Month 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in mMASI scores. |
Month 0 to Month 3 |
| Improvement in Tone Homogeneity |
Month 0 to Month 3 |
| Mean change in Melanin & Erythema Indices. |
Month 0 to Month 3. |
| Subject perceived efficacy by Patient Global Assessment. |
Month 3 |
| Change in subject’s quality of life by Melasma Quality of Life survey. |
Month 1 & 3 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/01/2024 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drprashantipatil@gmail.com].
- For how long will this data be available start date provided 01-09-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is to compare the efficacy and tolerability of a
novel test product in the management of epidermal melasma. This study is
designed as a prospective, single arm, open label study. A total of 40
subjects, fulfilling the inclusion and exclusion criteria, will be enrolled in
the study. All enrolled subjects will receive the test product and will be
followed at Baseline (Month 0), Month 1, Month 2, Month 3, and Month 4.
The efficacy and tolerability parameters will be assessed by
various methods, including dermatological examination, digital examination
(Visage-LS), and subject self-assessment, for the entire study period.
|