| CTRI Number |
CTRI/2025/01/079305 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate efficacy and safety of 4 test products on subjects with mild to moderate acne. |
|
Scientific Title of Study
|
To assess the effectiveness of Topical Formulae for their efficacy on skin acne related imperfections through instrumental and dermatologist assessment on mild to moderate acne over 4-week daily 2X usage in healthy adult subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B05299, Version# 02; 11 Jan 25 |
Protocol Number |
| C3B05299; Version: 01, Dated 23 Dec 24 |
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,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad.
Ahmadabad
GUJARAT
380054
India |
| Phone |
8980008193 |
| Fax |
|
| Email |
pbambhania@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.
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.
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India |
| LOréal India Pvt. Ltd., 7th floor, Universal Majestic, Jeejabai Bhosale Marg, ACC Nagar, Chembur, Mumbai, Maharashtra 400071. |
|
|
Primary Sponsor
|
| Name |
LOréal India Pvt. Ltd. |
| Address |
7th floor, Universal Majestic, Jeejabai Bhosale Marg, ACC Nagar, Chembur, Mumbai, Maharashtra 400071 |
| Type of Sponsor |
Other [Cosmetic and Personal Care] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
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,
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 |
8980008193
pbambhania@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| OM- Institutional Ethics Committee |
Approved |
| OM- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects with mild to moderate acne. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Face Cleanser |
Cleansing face with standard cleanser.
1 ml of test product will be used as cleanser twice a day starting from Day 01 to Day 28.
Application of neutral moisturizer post application of test product
|
| Intervention |
Face Cleanser |
Cleansing face with standard cleanser.
1 ml of test product will be used as cleanser twice a day starting from Day 01 to Day 28.
Application of neutral moisturizer post application of test product |
| Intervention |
Face Cleanser & Mask |
Cleansing face with standard cleanser.
1 ml of test product will be used as cleanser once a day in morning starting from Day 01 to Day 28. Same product will be used as mask once a day in evening starting from Day 01 to Day 28.
Application of neutral moisturizer post application of test product
|
| Intervention |
Face Cleanser & Mask |
Cleansing face with standard cleanser.
1 ml of test product will be used as cleanser once a day in morning starting from Day 01 to Day 28. Same product will be used as mask once a day in evening starting from Day 01 to Day 28.
Application of neutral moisturizer post application of test product
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects with skin phototype III - V (Fitzpatrick phototype assessed based on ITA value)
2) Subjects having Body Mass Index in the range of 18 to 25 kg/m2.
3) Subjects having oily skin type and combination of oily, sensitive.
4) Subjects with mild to moderate acne severity based on IGA scale.
5) Subjects with PIH spot of 3mm & above.
6) Subjects presenting acne lesions count:
• more than/equal to 10 to less than/equal to 25 inflammatory acne lesions on whole face
• more than 25 to less than/equal to 100 non-inflammatory acne lesions on whole face
|
|
| ExclusionCriteria |
| Details |
1) Subjects who have used anti acne products in the last 30 days.
2) Subjects who are receiving topical or systemic treatments for acne and PIH within last 30 days.
3) Subjects undergoing dermatological procedures for skin lightening or using other marketed skin lightening products during the study period or in the past 6 weeks.
4) Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
5) Subject having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Dermatological assessment of acne lesions using counting method.
2) Instrumental assessment of intensity of PIH and bare skin.
3) Instrumental assessment of the size of PIH |
Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatological assessment of Acne Severity using grading scale |
Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42. |
| Dermatological assessment of Redness around Acne lesion and skin radiance using grading scale |
Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42 |
| Instrumental assessment of skin sebum level, face hydration, skin barrier function and skin brightening |
Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42 |
| Instrumental assessment of Redness around acne (a value & redness measurements), acne elevation & sebaceous pores |
Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 & Day 42. |
| Dermatological assessment of global efficacy and tolerance of products |
Day 03, Day 07, Day 14, Day 28 and Day 42. |
| Subjective assessment |
Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42. |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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)
|
10/02/2025 |
| 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="0"
Months="1"
Days="26" |
|
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
|
This
is a mono-centric, randomized, parallel group, assessor blinded, comparative
study to evaluate the effectiveness of 4 topical formulae on subjects 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.
Total
Study Duration: 56
days Washout
Period: Atleast 14 Days Treatment Period: 28 days from enrollment visit
(Day 01) Relapse Period: 14 days from end of
treatment (i.e., Visit 06)
All
eligible subjects will undergo clinical evaluation by a Dermatologist,
instrument evaluation and subjective evaluation. Safety will be assessed
throughout the study by assessing the local intolerances and monitoring adverse
events. |