| CTRI Number |
CTRI/2024/04/065910 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying Acne Creams: Their Effectiveness When Used Daily at Home for 12 Weeks |
|
Scientific Title of Study
|
Assessment of topical formulae in comparison to positive reference for their efficacy on skin acne related imperfections through instrumental and dermatologist assessment, over a 12 week daily 1x/2x home usage |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2324CICL027 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himadri Sinha |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
Dermatology room 32 B, First floor, Pusa Road, Rajinder Nagar,
New Delhi-110005, India
New Delhi
DELHI
110005
India |
| Phone |
9003237239 |
| Fax |
|
| Email |
h.sinha@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himadri Sinha |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
Dermatology room 32 B, First floor, Pusa Road, Rajinder Nagar,
New Delhi-110005, India
New Delhi
DELHI
110005
India |
| Phone |
9003237239 |
| Fax |
|
| Email |
h.sinha@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Vidushi Bazaz |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, First Floor, Pusa Road, Rajinder Nagar, New Delhi-
110005, India
New Delhi
DELHI
110005
India |
| Phone |
9873348229 |
| Fax |
|
| Email |
v.bazaz@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| L’ORÉAL INDIA PVT. LTD.
7th Floor Universal Majestic, Ghatkopar- Mankhurd Link Road, Chembur
Mumbai-400071, India |
|
|
Primary Sponsor
|
| Name |
LOréal India Pvt. Ltd |
| Address |
7th Floor, Universal Majestic, Ghatkopar- Mankhurd Link Road,
Chembur, Mumbai- 400071, India |
| Type of Sponsor |
Other [Cosmetic company] |
|
|
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 Himadri Sinha |
CIDP Biotech India Pvt. Ltd. |
32-B, First Floor, Pusa Road, Rajinder Nagar, New Delhi-110005, India
New Delhi
DELHI |
9003237239
h.sinha@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects having oily
skin with acne will be screened in order to have 320 subjects in Phase I and 280 subjects in Phase II and 280 subjects will be
enrolled & randomized in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA
|
| Intervention |
Skin Care Product |
Product 1: Fla – 818963 80
Product 2: Fla– 818963 EF2
Product 3: Fla – Ab56612
Product 4: Fla – Eb56622
Timepoints of the Interventions- D0(Visit2), D7(Visit3), D14(Visit4), D28(Visit5), D56(Visit6), D84(Visit7)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy Male & Female subjects aged 18 - 35 years (both included) (subjects to be enrolled in equal ratio as per gender).
2 Subjects having skin phototype IV and V (Fitzpatrick) (subjects to be enrolled in equal ratio as per phototype)).
3 Subjects having body Mass Index in the range of 18 to 25 kg per meter square.
4 Subjects having oily skin type according to investigator
5 Subjects with mean sebum casual level on forehead less than 100 μg per cm square.
6 Subjects presenting with mild (grade 2) to moderate acne (grade 3) (max 2 nodules) severity on an IGA scale from 0 to 4, according to the investigator.
7 Subjects presenting acne lesion count:
less than equal to 10 to greater than equal to 25 inflammatory acne lesions on whole face (Forehead, cheeks, nose, jawline and chin).
less than 25 to greater than equal to 100 non-inflammatory/comedonal acne lesions on Forehead, cheeks, nose, jawline and chin.
max 2 nodules (greater than 1cm).
8 Subjects having a well-defined homogenous PIH spot of less than equal to 3mm on whole face with adjacent non-pigmented skin.
9 Subjects willing not to go for U.V. sessions/sun tanning/sun-bathing during the study duration.
10 Subjects agreeing to use only the supplied washout product and investigational product provided during the study.
11 Subjects informed about the study objectives and procedures and able to understand them.
12 Subjects willing and able to fulfil the study requirements and schedule.
13 Subjects willing to provide written informed consent and are able to understand English or Hindi.
14 Subjects willing to avoid oily, greasy, junk food and high sugar food items, as much as possible during the study period.
15 Subjects willing not to apply hair oil and wash their hair within 48 hours prior to the assessment visit.
16 Subjects willing to not to expose themselves in sun and must carry umbrella/cap/hat if going out.
17 Female of childbearing potential willing to undergo urine pregnancy test [self-declared by subject on screening visit and test to be done on Visit 2 (Baseline visit), Visit 5, Visit 6, Visit 7 & Visit 8.
18 Female of childbearing potential, who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study.
|
|
| ExclusionCriteria |
| Details |
1 Subjects who are pregnant or lactating or who are planning to become pregnant during the study.
2 Subjects who have used anti-acne products within the last 30 days.
3 Subjects who have only noticed an increase of acne due to protective face mask usage.
4 Subjects that are under the treatment/care of a dermatologist.
5 Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study.
6 History of allergies, hypersensitivity or any serious reactions to any cosmetic products.
7 Any significant skin pathology in the test areas, like rosacea, or eczema.
8 Any significant medical condition that would interfere with the participation in the study, as per the opinion of the Investigator.
9 Any concomitant medical/surgical condition or using medication which may harm the subject or may interfere with the study assessments, as per opinion of the Investigator.
10 Any dermatological procedure on the test areas (laser peel, dermabrasion etc.) taken 4 weeks before the start of the study and during the study.
11 Subject reported or planning to sun-bathe or to overexpose to UV-light (mountains sports, phototherapy, tanning salon use…) for aesthetic or therapeutic reason the month before the study start or during the study.
12 Having participated in the last 30 days before screening or currently participating in another clinical study.
13 Unable to be contacted by phone in case of emergency.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy of four topical formulae on acne prone and oily skin of subjects as
determined by below mentioned parameters:
✓ Acne lesion counts (inflammatory & non-inflammatory).
✓ Clinical grading of Acne using IGA scale.
✓ Evaluation of sebum casual level and sebum excretion rate using Sebumeter SM 815®.
2. To compare topical formulae effectiveness in reducing the contrast (between spots and bare
skin) and intensity of PIH spots (Less than equal to 3mm) by instrumental measurements with
Spectrophotometer.
3.To compare efficacy of four topical formulae in their effect on skin barrier function by
measurement of TEWL and hydration level. |
D-14, D0,D7, D14,D28, D56, D84, D98 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
06/05/2024 |
| 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="3"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To compare the efficacy of four topical formulae on acne prone and oily skin of subjects as determined by below mentioned parameters:
Acne lesion counts (inflammatory & non-inflammatory).
Clinical grading of Acne using IGA scale.
Evaluation of sebum casual level and sebum excretion rate using Sebumeter SM 815®.
- To compare topical formulae effectiveness in reducing the contrast (between spots and bare skin) and intensity of PIH spots (less than equal to 3mm) by instrumental measurements with Spectrophotometer
- To compare efficacy of four topical formulae in their effect on skin barrier function by measurement of TEWL and hydration level.
|