| CTRI Number |
CTRI/2024/12/078067 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A 12-Week Study to Test the Effectiveness and Safety of a New Treatment for Reducing Dark Spots on the Face (Melasma) |
|
Scientific Title of Study
|
Randomized controlled comparative study to
evaluate the efficacy and tolerability of Test
Regimen in the treatment of facial
hyperpigmentation (Melasma) over 12 weeks |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/BSMS/2024-07 version 1.0 dated 03 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
Medical director at MS clinical research Pvt Ltd |
| Address |
MS Clinical Research Pvt. Ltd, Department of Skin Sciences,324 Second floor, 1st main road, Cambridge layout, ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara Kumari |
| Designation |
Director-Business and operations |
| Affiliation |
MS Clinical research |
| Address |
MS Clinical Research Pvt. Ltd, Department of Skin Sciences,324 Second floor, 1st main road, Cambridge layout, ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
manager- Techno commercial |
| Affiliation |
MS Clinical research |
| Address |
MS Clinical Research Pvt. Ltd, Department of Skin Sciences,324 Second floor, 1st main road, Cambridge layout, ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Beiersdorf AG
Beiersdorfstraße 1-9
22529 Hamburg
Germany |
|
|
Primary Sponsor
|
| Name |
Beiersdorf AG |
| Address |
Beiersdorf AG
Beiersdorfstrasse 1-9
22529 Hamburg Germany |
| Type of Sponsor |
Other [FMCG] |
|
|
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 |
MS Clinical Research Pvt. Ltd, Department of Skin Sciences,324 Second floor, 1st main road, Cambridge layout, ulsoor.
Bangalore
KARNATAKA |
8040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy male and female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti-Pigment Day SPF 30 |
Dispense a sufficient amount (one fingertip unit) of Test
regimen.
Apply dots on the face (on each cheek, on the chin, one
on the forehead and on the nose) during morning |
| Intervention |
Anti-Pigment Dual Serum |
Apply a thin coat of Test regimen on the full face,
primarily focusing on the melasma area both in the morning and
evening. |
| Intervention |
Anti-Pigment Night Care |
Dispense a sufficient amount (one fingertip unit) of Test
regimen.
Apply dots on the face (on each cheek, on the chin,
on the forehead and on the nose) during night |
| Comparator Agent |
control |
Skincare routine (moisturizer) as usual (without products against
facial hyperpigmentation).
SPF 50 will be provided, and re-application during the day as
needed. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adult subjects in general good health as determined from recent medical history,
general physical examination, dermatological assessment,
Subjects of Phototype from III to VI.
Subjects diagnosed with mild to moderate Melasma,
Subjects who have not used contraindicated products (irritants, other depigmenting
agents) in the past 8 weeks (as per the treatment category, as per dermatologists’
discretion,
Subjects willing to stop all other skin care products and diligently follow the pro
vided treatment plan,
Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations,
or any other active skin conditions on the face,
Subject who agrees not to use any other product/treatment/home remedy/ except
the provided products on their face during the study period other than the test reg
imen,
Subjects who agree not to carry out bleaching or any other procedures including
facial etc. on the face during the study period,
Subjects who agree not to be exposed to excessive sunlight. (Sun exposure not
more than half an hour daily and during that time use of an umbrella to cover face),
Subjects willing to give a voluntary written informed consent, photography re
lease and agree to come for regular follow-up, Subjects willing to abide by and comply with the study protocol.
Willing to sign a photography release
In case of hormonal treatment/contraception, subjects who have been on a stable
dose for at least 6 months and agree not to change or stop their treatment/
contraception medication/dose |
|
| ExclusionCriteria |
| Details |
Subject with any other signs of significant local irritation or skin disease,
Subjects using oral contraceptive pills or hormonal implants as birth control
measures during the study,
Subjects on hormonal therapy (contraceptive, TSH) for at least 6 months prior to
the study.
Subjects who are pregnant or breastfeeding (self-declared).
Subjects with childbearing potential or have plans of pregnancy (excluded by a
urine pregnancy test).
Subjects who recently had a skin-lightening procedure in the past 8 weeks or oral
photosensitizers or who underwent phototherapy in the past 1 month wash out.
Subjects using corticosteroids or under antiepileptic medications for the previous
six months.
Subjects with a history of any other dermatosis of the face or known photosensi
tivity or undergoing topical treatment with Sun Protection Factor in the past 1
month.
Subjects who are exposed to the sun on a regular basis, frequent tanning salons
or foresee exposure to the sun during the study or any facial procedure planned
during the course of the study,
Subjects with any other active skin condition that may interfere with the study re
sults.
Subjects with a known history of allergenic reactions to any components of the
products.
Subjects who have participated in any other clinical trial in the last 3 months.
Subjects with Inadequate language proficiency (spoken and written)
Subject’s Inability to be placed in the photography system
Subjects with Severe psychological illness or intellectual inability to understand
the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in mMASI and change from Baseline
ï‚· Change in Investigator Global Assessment, in terms of the proportion
of subjects across the 5-point IGA scores.
ï‚· Change from Baseline based on instrumental assess
ment for pigmentation |
baseline at weeks 2,4,8, and 12. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subject Self-grading, in terms of raw value for each question
Quality of Life by MelasQol questionnaire, in terms of raw value, change, and change
from Baseline of total score. Eucerin Life Quality Index questionnaire.
Evaluation of the local tolerance and
adverse events in relation to the investigational products during the study using a sub
ject diary and a severity scale |
baseline at weeks 2,4,8, and 12. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
23/12/2024 |
| 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
|
Melasma is a common skin condition characterized by the appearance of dark, irregular patches, primarily on the face. This dermatological study is an interventional, randomized controlled trial designed to compare the efficacy and tolerability of a new depigmenting cosmetic formulation for managing facial hyperpigmentation (melasma) over a 12-week period, with a total of 6 study visits. Participants will be fully informed about the study design and treatment plan and will have sufficient time to review the informed consent form (ICF). The dermatologist will assess the severity of melasma using the mMASI scale and determine the type of melasma with a Wood’s lamp examination. Eligible subjects will be selected based on the inclusion and exclusion criteria. Participants will be instructed to wash their faces with the provided facewash and allow a 10-minute acclimatization period. After this, baseline assessments will be conducted, and test regimens, along with a subject diary, will be provided. Similar assessments will be repeated at weeks 3, 4, 8, and 12. At the conclusion of the study, the test regimens and subject diaries will be collected, and participants will be asked to complete the study exit form. |