| CTRI Number |
CTRI/2025/10/095866 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of a Sunscreen tablet in humans with pigmentation. |
|
Scientific Title of Study
|
To evaluate Efficacy and in use tolerance of Oral Sun Protection Nutraceutical Tablet in Men and Women with Melasma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/079/0825/STU Version No.: 1 of 09th September 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator - Consultant Dermatologist |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| Ajanta Pharma Limited
Ajanta Tower
54, Sir Mathuradas Vasanji Rd, Hanuman Nagar, Andheri East, Mumbai, Maharashtra 400093 |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Limited |
| Address |
Ajanta Tower
54, Sir Mathuradas Vasanji Rd, Hanuman Nagar,
Andheri East, Mumbai, Maharashtra 400093 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Rajiv Joshi |
Clinical Aesthetics and Investigative Management Services Pvt. Ltd |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA |
66758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLAIMS Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers with pigmentation will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BanRay Oral Sun Protection Nutraceutical Tablet |
One Tablet to be taken Once daily after breakfast, orally, to be swallowed with water for a duration of 60 days. |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and or women from 18 years to 55 years of age with mild to moderate
melasma will be included.
2. Photo type III to IV.
3. Having otherwise healthy skin on test area.
4. Participants showing abnormal levels in blood test parameters. (Subjects having abnormal
values but are Clinically fit to participate in the trial would be enrolled in the study at
Principal Investigator’s Discretion).
5. Willing to avoid unusual sun exposure as far as possible for the entire study duration.
6. Accepting not to use oral supplement with the same end benefit during the entire study
duration.
7. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
8. Ready to provide consent, having been informed orally and in writing of all information
concerning the study procedures and study objectives. |
|
| ExclusionCriteria |
| Details |
1. Female who is pregnant (UPT)or lactating women.
2. Participants hypersensitive to any of the components of the test product.
3. Participants on any systemic medical treatment which may interfere with the performance of
the study treatment (presently or in the past 1 month).
4. Participant in an exclusion period or participating in any clinical trial within 30 days prior to screening. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 3D Imaging for Skin Tone evenness and hyperpigmentation.
2. Melasma Area Severity Index (MASI Scale) for the assessment of melasma.
3. Self-assessment for product efficacy. |
Day 0, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self-assessment questionnaire for in use tolerance. |
Day 30, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
27/10/2025 |
| 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="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 - NO
|
|
Brief Summary
|
The skin is a major protective organ of the body. It is constantly exposed to the environment and is very resilient. But exposure to ultraviolet (UV) rays from the sun results in the production of reactive oxygen species (ROS) and subsequent inflammatory responses that can overwhelm the innate protective mechanisms of the skin. This results in damage and premature aging. Strategies to mitigate this premature photoaging might include avoidance of sunlight. However, some sunlight exposure is beneficial to health. One notable example of this is the production of vitamin D. A more practical approach to preventing adverse effects of UV light in the skin is antioxidant supplementation. Dietary antioxidants may help control ROS propagation following UV light exposure. To further evaluate the utility of antioxidants in protecting the skin a study will be required. This study will be carried out to evaluate Safety and Efficacy of Oral Sun Protection Nutraceutical Tablet in Men and Women with Melasma using objective instrument measurements, clinical evaluation and subjective self-assessment. |