| CTRI Number |
CTRI/2022/08/044646 [Registered on: 04/08/2022] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the safety and efficacy of a cream in reducing skin pigmentation in healthy pregnant females and lactating females with Mild to Moderate Melasma. |
|
Scientific Title of Study
|
An open-label, single-arm study to evaluate efficacy and safety of a cream in reducing skin pigmentation in healthy pregnant female (1st and 2nd trimester) and lactating female (post pregnancy mother having 0 month to 18 months old baby) subjects with Mild to Moderate Melasma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00044 Version: 01, Dated 15 Jul 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director - Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
917966219549 |
| Email |
ssethi@ofacto.com |
|
|
Source of Monetary or Material Support
|
| Zydus Wellness Ltd
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment,
Opp Viola Apartment,
Ambli Bopal Road,
Ahmedabad 38001, India |
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Ltd |
| Address |
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment,
Opp Viola Apartment,
Ambli Bopal Road,
Ahmedabad 38001, India |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
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 Parth Joshi |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
8000085049
917966219549
pjoshi@ofacto.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melasma Cream |
Approx. 2 gm of test product to be applied on affected area.
Twice a day application for a period of 140 days.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Sex: Females, either of the following
a. Healthy pregnant females (1st and 2nd trimester – preferably first half of the 2nd trimester).
b. Post-pregnant females (post pregnancy mother having 0 month to 18 months old baby) at the time of consent.
2) Subjects with mild to moderate melasma determined by Melasma Area and Severity Index (MASI) score.
3) Subjects having at least 2 hyperpigmentary spots on the face.
4) Atleast 10 subjects with hypopigmentation along with melasma and at least 2 hyperpigmentary spots on the face.
5) Subjects who have a history of delivery within 42 weeks (applicable for post-pregnant females only).
|
|
| ExclusionCriteria |
| Details |
1) Subjects who have pigmentation due to any other reason than exposure to UV light like result of hormonal changes, freckles.
2) Subjects with skin disease (e.g., moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, atopic dermatitis or any other condition as per Investigators discretion), which would interfere with the assessment area.
3) Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
4) Participation in a similar clinical study within the previous 90 days.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Dermatological evaluation of the severity of melasma using Melasma Area and Severity Index (MASI) Score
2)Evaluation of skin hyperpigmentation using Mexameter
|
Baseline, Week 4, Week 12, Week 20 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of dark spot /blemishes /hypopigmentary spots using Chromameter. |
Baseline, Week 4, Week 12, Week 20 |
| Dermatological evaluation of skin radiance using modified Griffiths Scale. |
Baseline, Week 4, Week 12, Week 20 |
| Evaluation of uneven skin tone using Felix Von Luschan Skin colour chart. |
Baseline, Week 4, Week 12, Week 20 |
| Evaluation of skin pigmentation /melasma /hypopigmentation by image analysis. |
Baseline, Week 4, Week 12, Week 20 |
| Subject Satisfaction Questionnaire and Product Response Index (Perception about Product). |
Baseline, Week 4, Week 12, Week 20 |
| Photographs by VISIA CR |
Baseline, Week 4, Week 12, Week 20 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The potential
subjects will be screened as per the inclusion and exclusion criteria only
after obtaining written informed consent from the subjects.
There are total 5 visits in the study i.e.
·
Visit 01: Screening Visit (within 30 days prior to day
01)
·
Visit 02: Enrolment (Week 1, Day 01)
·
Visit 03: Evaluation phase (Week 4, Day 28 ± 2 days)
·
Visit 04: Evaluation phase (Week 12, Day 84 ± 2 days)
·
Visit 05: Evaluation phase and End of the study (Week
20, Day 140 ± 2 days)
Before
entering the facility, at security check-post, subjects will be asked for
pre-entry scrutiny check for COVID-19 symptoms. Study can be conducted in
multiple batches (set of subjects) in order to follow the norms of covid-19
restrictions.
Instrumental
assessment, dermatological assessments and questionnaires will be assessed.
Photographs will be taken using VISIA-CR. Images will be analyzed using Image
Pro Software/3D analysis system. Safety will be assessed throughout the study
by monitoring of adverse events. |