| CTRI Number |
CTRI/2024/12/077776 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [efficacy study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing of Acne products on India males & females using dermatologist & instrumental evaluation |
|
Scientific Title of Study
|
ASSESSMENT OF TOPICAL FORMULAE FOR THEIR EFFICACY ON SKIN ACNE RELATED IMPERFECTIONS THROUGH INSTRUMENTAL AND DERMATOLOGIST ASSESSMENT OVER 8 WEEK DAILY 1X 2X HOME USAGE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranami Kashyap |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, First floor, Rajendra Nagar, Pusa Road, New Delhi-110005 INDIA
Central
DELHI
110005
India |
| Phone |
09999442984 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranami Kashyap |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, First floor, Rajendra Nagar, Pusa Road, New Delhi-110005 INDIA
Central
DELHI
110005
India |
| Phone |
09999442984 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Kashyap |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, First floor, Rajendra Nagar, Pusa Road, New Delhi-110005 INDIA, New Delhi, Delhi 110005
Central
DELHI
110005
India |
| Phone |
09999442984 |
| Fax |
|
| Email |
a.kashyap@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 |
L’ORÉAL INDIA PVT. LTD. |
| Address |
7th Floor Universal Majestic, Ghatkopar- Mankhurd Link Road, Chembur Mumbai-400071, India |
| Type of Sponsor |
Other [Research center ] |
|
|
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 Pranami Kashyap |
CIDP Biotech India Pvt Ltd |
32-B, First floor, Rajendra Nagar, Pusa Road, New Delhi-110005 INDIA, New Delhi, Delhi 110005
Central
DELHI |
9999442984
a.kashyap@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with acne prone and oily skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cosmetic product for reducing acne (Leave on cream) |
The product will be applied twice daily (morning and evening) in a dosage of 0.6g |
| Intervention |
Cosmetic product for reducing acne (Serum) |
The product will be applied once daily (evening) in a dosage of 0.6g |
| Intervention |
Cosmetic product for reducing acne (Serum) |
The product will be applied once daily (evening) in a dosage of 0.6g |
| Intervention |
Cosmetic product for reducing acne (Serum) |
The product will be applied twice daily (morning and evening) in a dosage of 0.6g |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy Male & Female subjects aged 18 to 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 kilogram per square meter (BMI can be relaxed to 30 kilogram per square meter in case of recruitment challenges)
4) Subjects having oily skin type according to investigator
5) Subjects with mean sebum casual level on forehead less than100 microgram/Square Centimeter
6) Subjects presenting with mild (grade 2) to moderate acne (grade 3) severity on an IGA scale from 0 to 4 according to the investigator.
7) Subjects presenting acne lesion count:
More than 10 to less than 25 inflammatory acne lesions on whole face (Forehead, cheeks, nose, jawline and chin). (mean value without nose around 15 to 16)
More than 25 to less than 00 non-inflammatory/comedonal acne lesions on Forehead, cheeks, nose, jawline and chin. (mean value without nose around 60 to 65)
max 2 nodule (less than 1cm)
8) Subjects having a well-defined homogenous PIH spot of less 3mm on whole face with adjacent non-pigmented skin.
9) Subjects willing not to go for UV 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 7 Visit 8 & Visit 9
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.
Prevention of PIH by monitoring the evolution of 6-8 target inflammatory lesions (6-8papules &/or 2 pustules) for residual pigmentation.
Evaluation of sebum casual level and sebum excretion rate using Sebumeter SM 815®.
Redness around acne by Dermat & by using Antera 3D®imaging.
Clinical grading for reduction in redness around two target inflammatory lesions (L&R). |
Visit 1: Day-14 to Day -1
Visit 2: Day 0 ± 2 days
Visit 2: Day 0 Timm
Visit 3: Day 3±1 day
Visit 4: Day 7±1 day
Visit 5: Day 14± 2 days
Visit 6: Day 21± 2 days
Visit 7: Day 28± 2 days
Visit 8: Day 56± 2 days
Visit 9: Day 70± 2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy of topical formulae in reducing and preventing pigmentary spots by below mentioned parameters:
Evaluation of Density of Pigmentary spots (PIH spots only) using the Indian Atlas.
Evaluation of Contrast of Isolated Pigmentary spot (≥3mm PIH spot) using the Indian Atlas.
Reduction in size of one single PIH spot (≥3mm PIH spot) measured by Vernier calliper /Ruler scale.
|
Visit 1: Day-14 to Day -1
Visit 2: Day 0 ± 2 days
Visit 2: Day 0 Timm
Visit 3: Day 3±1 day
Visit 4: Day 7±1 day
Visit 5: Day 14± 2 days
Visit 6: Day 21± 2 days
Visit 7: Day 28± 2 days
Visit 8: Day 56± 2 days
Visit 9: Day 70± 2 days |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "280"
Final Enrollment numbers achieved (India)="280" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
09/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/05/2025 |
|
Estimated Duration of Trial
|
Years="24"
Months="4"
Days="25" |
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
|
The purpose of the trial is to check the efficacy of acne products on acne oily skin of Indian males and females of age 18 years to 35 years |