| CTRI Number |
CTRI/2023/03/050575 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
27/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the Safety and Efficacy of 1 test product in reducing dark spots on the face. |
|
Scientific Title of Study
|
A clinical study to evaluate Safety, In-Use Tolerability and Efficacy of HTSS-052203 in reducing the facial dark spots in Healthy Adult Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B02786;HWC/MSCD/CPD/004/2023; Ver: 01, Dated 16 Feb 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Purva Yadav |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot, Off S.G. Highway,
Bodakdev, Ahmedabad – 380054
Ahmadabad
GUJARAT
380054
India |
| Phone |
8980008193 |
| Fax |
|
| Email |
pbambhania@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Co-Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot, Off S.G. Highway,
Bodakdev, Ahmedabad – 380054
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot, Off S.G. Highway,
Bodakdev, Ahmedabad – 380054
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot, Off S.G. Highway,
Bodakdev, Ahmedabad – 380054, India |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Makali, Bengaluru 562 162, 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 Purva Yadav |
Cliantha Research |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway,
Bodakdev, Ahmedabad – 380054
Ahmadabad
GUJARAT |
8980008193
pbambhania@cliantha.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 |
| Healthy Human Volunteers |
Males & non-pregnant/non-lactating females between the ages of 18-55 years old (both inclusive) at the time of consent with facial dark spots (suntan, blemishes, sunspots & age-spots) & oily skin. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HTSS-052203 |
3 to 5 drops of test product to be applied on face and massage gently until it gets absorbed. To be used once a day. |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Subject has at least 2 dark spots on the face (suntan, blemishes, sunspots and age-spots). Preferably equal number of subjects will be recruited in all indications.
2) Subjects with mild to moderate dark spots as per Investigator global assessment (IGA).
3) Subjects with oily skin having Sebumeter measurement > 180 (μg/cm2).
|
|
| ExclusionCriteria |
| Details |
1) Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
2) Subjects who are receiving topical or systemic treatments / undergoing skin lightening treatment.
3) Subjects receiving medications (e.g., steroids or antihistamines) which would compromise the study.
4) Subjects with chronic illness which may influence the cutaneous state.
5) Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
6) Subjects using other marketed anti-acne/anti-aging/skin lightening products during the study period or in the past 6 weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Assessment of dark spots using Investigator global assessment (IGA).
2) Assessment of skin pigment using 9-point scale.
3) Assessment of dark spots using Mexameter.
4) Assessment of skin sebum level using Sebumeter |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 282) Assessment of skin pigment using 9-point scale.
3) Assessment of dark spots using Mexameter.
4) Assessment of skin sebum level using Sebumeter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of uneven skin tone using Felix Von Luschan Skin colour chart |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of the colour of dark spot using Chromameter |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of Skin radiance using Modified Griffiths Scale |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of Skin gloss using Skin-Glossymeter |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of Skin Moisturization using Corneometer / MoistureMeterSC |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using TEWAmeter / Vapometer |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of skin elasticity using Cutometer |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of dark spots and skin texture (roughness) using 3D analysis system |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of Subject Satisfaction Questionnaire after product usage |
Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28 |
| Assessment of Product Response Index (Perception about Product) after product usage |
Day 28 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2023 |
| Date of Study Completion (India) |
19/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is an open label, single-arm, clinical study to evaluate safety, in-use
tolerability and efficacy of HTSS-052203
in healthy adult human subjects with facial dark spots (suntan, blemishes,
sunspots and age-spots) and oily skin.
The
potential subjects will be screened as per the inclusion and exclusion criteria
only after obtaining written informed consent from the subjects.
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.
All
eligible subjects will undergo clinical evaluation by Dermatologist, instrument
evaluation and subjective evaluation. Safety will be assessed throughout the
study by monitoring of adverse events. |