| CTRI Number |
CTRI/2023/10/058218 [Registered on: 03/10/2023] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| 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, In-Use Tolerability and Efficacy of a test product in reducing acne and acne spots on the face. |
|
Scientific Title of Study
|
A clinical study to evaluate Safety, In-Use Tolerability and Efficacy of HARF-042202 in healthy adults with mild to moderate acne and acne prone skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B03519; HWC/MSCD/CPD/029/2023; Ver: 01, Dated 14 Sep 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagirath Patel |
| 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 |
9825618138 |
| Fax |
|
| Email |
bhagirathrpatel1818@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Trial Coordinator |
| 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 |
| Himalaya Wellness Company
Makali, Bengaluru 562 162, 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 Parth Joshi |
Cliantha Research |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot, Off S.G. Highway,
Bodakdev – 380054
Ahmadabad
GUJARAT |
8000085049
pjoshi@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects of both sex (preferably with equal numbers) with age between 12 and 30 years (both inclusive at the time of consent/assent) having acne-prone skin and with mild to moderate acne. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HARF-042202 |
Moisten the face and apply approximately 3ml of test product. Lather will be gently worked up using a circular motion. Rinse the Face thoroughly and pat dry. Use the product twice daily (morning and evening). |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects having good general health as determined by the Investigator on the basis of medical history. Subjects with acne-prone skin and with mild to moderate acne condition as per IGA scale and acne prone skin.
2) Subjects with oily skin having Sebumeter measurement > 180 (μg/cm2).
3) Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening and enrolment visit.
4) Subjects who are not under any dermatologic treatment for acne and scar/ prescribed medications. |
|
| ExclusionCriteria |
| Details |
1) Subjects with drug induced acne as disclosed by subjects.
2) Subjects undergoing treatment for skin lightening or subjects using other marketed skin lightening products during the study period or in the past 6 weeks.
3) Subjects who are receiving topical or systemic treatments for acne or acne marks.
4) Subjects receiving medications (e.g., steroids or anti-histamines) which would compromise the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of acne severity (in terms of reducing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions. |
Day 01 (before application to Day 29 (plus 2 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of acne severity (in terms of reducing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions |
Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days) and Day 15 (plus 2 days) |
| Assessment of acne severity (in terms of preventing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions |
Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) Day 29 (plus 2 days) |
| Assessment of Skin dryness using 5-point grading scale by Dermatologist |
Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of Skin redness using 5-point grading scale by Dermatologist |
Day 01 (before application and 8 hours post product application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of Skin desquamation/flakiness using 5-point ordinal scale by Dermatologist |
Day 01 (before application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of skin pigmentation using 9-point grading scale |
Day 01 (before application), Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of skin sebum level using Sebumeter SM 815 |
Day 01 (before application, 30 mins, and 8 hours post product application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of skin moisturization using MoistureMeterSC |
Day 01 (before application, 30 mins, and 8 hours post product application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using Vapometer |
Day 01 (before application), Day 02 (24 hr. post application), Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of porphyrins using Visiopor |
Day 01 (before application), Day 02, (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of Subject Satisfaction Questionnaire after product usage |
Day 01 (8 hours post product application), Day 02 (24 hr post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
| Assessment of Product Response Index (Perception about Product) after product usage |
Day 29 (plus 2 days) |
| Assessment of acne, erythema and acne marks/spots using 3D analysis system using Antera |
Day 01 before application and 8 hours post application, Day 02 (24 hr), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days) |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2023 |
| Date of Study Completion (India) |
21/12/2023 |
| 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
|
N/A |
|
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, non-randomized, single-arm clinical study to evaluate safety,
in-use tolerability and efficacy of test products in
healthy human subjects with acne-prone skin and with mild to moderate acne.
The potential
subjects will be screened as per the inclusion and exclusion criteria only
after obtaining written informed consent from the subjects.
All eligible
subjects will undergo clinical evaluation by a Dermatologist, instrument
evaluation and subjective evaluation. Safety will be assessed throughout the study by
monitoring adverse events. |