| CTRI Number |
CTRI/2025/08/093382 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Efficacy & safety study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to check the effectiveness and Safety of the Serum with Microneedling Compared to Microneedling Alone for Reducing Hyperpigmentation. |
|
Scientific Title of Study
|
Evaluation of the efficacy and tolerability of MelaB3 serum as an adjunct to microneedling, versus microneedling alone in the treatment of Melasma and PIHP in Indian adult population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/LPMP/2025-01 version 1.0 dated 01 Aug 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road Cambridge layout, Ulsoor
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 |
| 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
|
| La Roche-Posay Laboratoire Dermatologique,
62 quai Charles Pasqua, 92300 Levallois-Perret, France |
|
|
Primary Sponsor
|
| Name |
La Roche-Posay Laboratoire Dermatologique |
| Address |
62 quai Charles Pasqua, 92300 Levallois-Perret, France |
| 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 |
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 Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and female participants having melasma or PIH |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MelaB3 serum + microneedling procedure |
Trial participants will apply the product at home twice daily (morning and evening) during the study and undergo three microneedling sessions at Day 1, Day 28, and Day 56. |
| Comparator Agent |
Microneedling procedure |
Trial participants will undergo three microneedling sessions at Day 1, Day 28, and Day 56. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants aged above 18 to 65 years
2. Fitzpatrick skin phototypes III to V
3. Trial participants must present with only one facial pigmentary condition either melasma or PIHP
4. Trial participants in good general and mental health in the opinion of the investigator
5. Trial participants demonstrating understanding of the study procedures restrictions and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the consent form |
|
| ExclusionCriteria |
| Details |
1.Female trial participants who are pregnant or nursing woman or woman planning to get pregnant during the study (self-perceived)
2.Female trial participant who gave birth less than 3 months prior to Day -14, who is pregnant, breast-feeding or who plans to become pregnant during the study;
3.Male trial participant with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline);
4.Trial participant with known allergy to any ingredients of the test products (tested product and sunscreen);
5.Trial participant with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate & Compare the efficacy levels between treatment groups by Change from Baseline in participants with melasma & PIH by dermatological and instrumental assessments |
D1,D28, D56, D84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate & Compare the efficacy & safety of the serum by participant self-assessment questionnaire and by dermatological evaluation. |
D1,D28, D56, D84 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/09/2025 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study aims to evaluate the clinical efficacy and safety of combining MelaB3 (MB3) serum with microneedling in the treatment of melasma and post-inflammatory hyperpigmentation (PIHP), compared to microneedling alone. The study will span approximately 3.5 months for each participant and include a total of five visits. Eligible participants will be randomly assigned to one of two groups: Group 1 will receive microneedling along with the test product (MelaB3 serum), and Group 2 will receive microneedling alone. Study assessments will be conducted at regular intervals on Day 1, Day 28, Day 56, and Day 84 to evaluate both efficacy and safety outcomes. |