| CTRI Number |
CTRI/2025/01/079811 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Chemical peel study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effectiveness and safety of chemical peel treatment with homecare products in reducing melasma in 18 male and female adult participants. |
|
Scientific Title of Study
|
An interventional clinical trial to evaluate the efficacy and safety of 3 peel sessions of Activa Peel Forte and Mela Peel Forte combined with Dermaceutic homecare products in adults with skin of color suffering from melasma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/DCCP/2024-01 Version 1.0 dated 30 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 |
MS Clinical Research Pvt. Ltd
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout, Ulsoor
MS Clinical Research Pvt. Ltd,
36-1,1st Main Road,
Cambridge Layout,
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917243 |
| 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 |
#324, Second Floor,
1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917243 |
| 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 |
#324, Second Floor,
1st Main Road, Cambridge Layout, Ulsoor, Bangalore - 560008, Karnataka, India
Bangalore
KARNATAKA
56008
India |
| Phone |
08040917243 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Dermaceutic Laboratoire
Dermosciences España
Gran Via de les Corts Catalanes, 583, Barcelona 08011 Spain |
|
|
Primary Sponsor
|
| Name |
Dermaceutic Laboratoire, Dermosciences España |
| Address |
Gran Via de les Corts Catalanes, 583, Barcelona (08011), Spain. |
| Type of Sponsor |
Other [Cosmeceutical Industry] |
|
|
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 |
#324, Second Floor,
1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA |
08040917243
mukta.sachdev@msclinical.com |
|
Details of Ethics Committee
Modification(s)
|
| 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 participant with melasma |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Activa Peel Forte |
chemical peel product.
Onsite Application quantity: as required by the professional applicator
Duration: Onsite Visit 2, 3 and 4 |
| Intervention |
Mela Peel Forte |
chemical post-peel cream.
Application quantity: as required
Duration: from baseline to visit 5 every night.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant with Melasma.
2. Participant free of excessive hair, acne, wounds or any other active skin conditions on face.
3. Participant who agrees not to participate in any other clinical research
4. Participant with skin phototype IV to VI according to Fitzpatrick scale
5. Participant willing to refrain from using any other product/ home remedies that could affect the skin, aside from the study products |
|
| ExclusionCriteria |
| Details |
1. Participant with dry and sensitive skin.
2. Participant having active skin diseases.
3. Female participant who are pregnant or lactating.
4. Participant who has taken any oral medications or systemic corticosteroids, anti-fungal, antibiotics, hormonal therapy (including oral contraceptives), or any prolonged use of non-steroidal anti-inflammatory, or anti-histaminic within 4 weeks prior to the study.
5. Participant who has undergone any dermatological procedure or facial surgery which might interfere in the study based on investigator’s assessment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of chemical peel combined with at home skincare regimen in treating melasma through dermatological evaluation, instrumental evaluation and digital imaging |
Visit 2
Visit 3
Visit 4
Visit 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of safety and tolerability of chemical peel by the collection of adverse event and participants questionnaires. |
Visit 2
Visit 3
Visit 4
Visit 5 |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2025 |
| Date of Study Completion (India) |
26/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 hyperpigmentation disorder characterized by irregular, dark, discolored patches primarily appearing on the face often influenced by factors such as sun exposure, hormonal changes, genetics, and certain medications. Treatment for melasma is often tailored based on the severity and the underlying cause chemical peels have become a popular, non-invasive solution for the treatment of melasma.This study aims to evaluate the efficacy and safety of Activa Peel Forte and Mela Peel Forte combined with dermaceutic homecare products in adults with skin of colour suffering from melasma. The study will be conducted over 14 weeks and will include five visits: Visit 1 (screening), followed by four assessment visits (Visit 2, Visit 3, Visit 4, and Visit 5). During the screening visit, participants will undergo a dermatological assessment to confirm the presence of melasma. Eligible participants will receive test products, a subject diary, and detailed instructions on their usage. At each assessment visit, dermatological evaluations, imaging assessments, safety evaluations, and instrumental assessments will be performed to monitor progress and evaluate outcomes. Additionally, chemical peel procedures will be included during visit 2, 3, 4. |