| CTRI Number |
CTRI/2024/12/078070 [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) [anti pigment regimen with LASER therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to test the effectiveness of combining an anti-pigment regimen with LASER therapy for treating dark spots on the face (melasma) |
|
Scientific Title of Study
|
A randomized, controlled study to evaluate the efficacy and tolerability of Eucerin® Anti-Pigment regimen as an adjunctive treatment for melasma before and after non-ablative LASER therapy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/BSLS/2024-08 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 |
MS Clinical Research Pvt. Ltd. |
| Address |
Department of Skin Sciences,
324 Second Floor,
1st Main Road, Cambridge Layout
Ulsoor
36-1,1st Main Road, 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 Pvt. Ltd. |
| Address |
327/15, 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 Pvt. Ltd. |
| Address |
327/15, 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 |
Beiersdorfstrasse 1-9
22529 Hamburg
Germany
|
| 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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd. |
Department of Skin Sciences,
324 Second Floor,
1st Main Road, Cambridge Layout
Ulsoor
Bangalore
KARNATAKA |
08040917253
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 females presenting with moderate to severe melasma |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AP Daycare Cream |
Dispense the 1 Finger-tip unit of cream onto your finger, apply 3 dabs on each cheek, one dab on the chin, one dab on the forehead and one dab on the nose. Massage the cream into your skin using circular motions. |
| Intervention |
AP Serum |
Apply a thin coat of the serum on full face, focusing on the melasma area in the morning and evening. |
| Intervention |
AP-Nightcare Cream |
Dispense the 1 Finger-tip unit of cream onto your finger, apply 3 dabs on each cheek, one dab on the chin, one dab on the forehead and one dab on the nose. Massage the cream into your skin using circular motions. |
| Comparator Agent |
non ablative LASER therapy using ALMA ClearSkin Er:Glass 1540nm |
The subject’s face will be cleansed thoroughly to remove any makeup, oils, or dirt.
A skin test will be performed on the intended treatment area before the treatment session. Skin condition will be assessed after 15-30minutes.
To protect the subject’s and dermatologist’s eyes from the LASER light, the eyes will be covered using protective LASER goggles throughout the procedure.
Once the skin is prepared, the applicator will be positioned perpendicular to the skin and passed over the treatment area with minimal overlap.
This will be done on visits 3 and 6. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Female subjects aged between 18-50 years (both ages inclusive)
2. Fitzpatrick skin phototype III to VI.
3. Subjects presenting with moderate to severe melasma (based on IGA) and intention to treat.
4. Subjects who have not used any depigmenting agent or undergone any melasma treatment in the past 4-6 weeks as per dermatologists’ discretion.
5. Subjects willing to stop all other skin care products usage on the test site and diligently follow the provided treatment plan.
6. Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacera-tions, or any other skin conditions on the face.
7. Subjects who agree not to use any other product/treatment/home remedy/ except the provided products on their face during the study period.
8. Subjects who agree not to carry out bleaching or any other procedures in-cluding facial etc. on face during the study period.
9. Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of an umbrella to cover face).
10. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
11. Subjects willing to abide by and comply with the study protocol.
|
|
| ExclusionCriteria |
| Details |
1. Subject with any other signs of significant local irritation or skin disease.
2. Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study.
3. Subjects on hormonal therapy (contraceptive, TSH) for at least 6 months prior to the study.
4. Subjects who are pregnant/ nursing (self-declared) or have plans of becoming pregnant during the study. Pregnancy in subjects of child bearing potential will be confirmed by urine pregnancy test.
5. 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.
6. Subjects using corticosteroids or under antiepileptic medications for the previous six months.
7. Subjects with a history of any other dermatosis of the face or known photo-sensitivity or undergoing topical treatment with sun protection factor in the past 1 month.
8. 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,
9. Subjects with any other active skin condition that may interfere with the study results.
10. Subjects with a known history of allergenic reactions to any components of the products.
11. Subjects who have participated in any other clinical trial in the last 3 months.
12. Subjects with inadequate language proficiency (spoken and written).
13. Subject’s inability to be placed in the photography system.
14. Subjects with severe psychological illness or intellectual inability to understand the study.
15. Employees of the CRO or the Sponsor. |
|
|
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 IGA scores at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline(TB1 and TB2).
•Change in the appearance of melasma using dermatological visual grading scores at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline (TB1 and TB2).
•Change in the appearance of melasma using VISIA CR at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline (TB1 and TB2).
•percentage change from baseline based on Spectrophotometer L for pigmentation. |
baseline 1, baseline 2, 4 days after baseline 2, week 2, week 4, week 8, week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Change in mMASI and IGA scores at all time points before and after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to control.
•Change in the appearance of melasma using dermatological visual grading scores at all time points before and after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to control.
•Change in MelasQoL status, ELQI status, self-assessment questionnaire at all time points in comparison to baseline (TB1 and TB2) and control group.
|
baseline 1, baseline 2, 4 days after baseline 2, week 2, week 4, week 8, week 12. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
24/12/2024 |
| 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 Yet Recruiting |
| 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 8 study visits. Participants will be 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. Eligible subjects will be selected based on the inclusion and exclusion criteria. Participants will be instructed to wash their face with the provided facewash and cclimatize for 10 minutes. After this, baseline assessments will be conducted, and test regimens, along with a subject diary, will be provided. Similar assessments will be repeated at baseline 2, 4 days after baseline2, week 2, week 4, week 8 and week 12. LASER therapy will be performed on Baseline 2 and week 4. 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.
|