| CTRI Number |
CTRI/2024/10/074716 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| 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 Purifying Neem Face Wash in healthy subjects with mild to moderate acne and acne prone skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04901; HWC/MSCD/CPD/043/2024;Version: 01, Dated 18 Sep 24 |
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, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bpatel3@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Study Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| 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 Bhagirath Patel |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat
Ahmadabad
GUJARAT |
9825618138
bpatel3@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 |
| Patients |
(1) ICD-10 Condition: L709||Acne, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Purifying Neem Face Wash |
Approx. 3 ml of product will be applied twice a day (morning and evening) for 29 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects with mild to moderate acne condition.
OR
Subjects who are prone to develop however with no existing acne.
2) Subjects with oily skin having Sebumeter measurement more than 150 (ug/cm2).
3) Subjects with acne marks/spots and post acne scar.
4) Subjects with visible facial pores.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with drug induced acne as disclosed by subjects.
2) Subjects undergoing treatment for skin lightening or 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, acne marks and acne scars.
4) Subjects receiving medications (e.g., steroids or antihistamines) would compromise the study.
5) Chronic illness which may influence the cutaneous state. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of test product on acne or acne prone skin, based on clinical, instrumental and subjective evaluations done at predetermined time points. |
Day 01 (before application and 15 mins), Day 02 (24hrs), Day 03 (48 hrs), Day 04 (72 hrs), Day 05 (+ 01 day), Day 07 (+ 02 days), Day 15 (+ 02 days) and Day 29 (+ 02 days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="133"
Sample Size from India="133"
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
19/11/2024 |
| 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)
|
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 Purifying Neem Face Wash in healthy
subjects with mild to moderate acne and acne prone skin.
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. |