| CTRI Number |
CTRI/2024/11/077105 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cosmetic Claim Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
This study checks if Demelan Face Wash could clog pores and cause breakouts. Using a "follicular biopsy" test, researchers examine small skin samples to see if the face wash blocks hair follicles. This helps ensure its safe for acne-prone skin. |
|
Scientific Title of Study
|
Evaluation of comedogenicity potential of the Demelan Face Wash by follicular biopsy test |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonal Shendkar |
| Designation |
Principal Investigator |
| Affiliation |
Skinovate Laser And cosmetic surgery center |
| Address |
Skinovate laser and cosmetic center Office No. 302 and 303, Third Floor, ‘Royal Avenue’, Survey No.18 Hissa No.11/6, Next to Hotel ‘Shivar Garden Pimple Saudagar, Rahatani, Maharashtra 411017
Skinovate laser and cosmetic center Office No. 302 and 303, Third Floor, ‘Royal Avenue’, Survey No.18 Hissa No.11/6, Next to Hotel ‘Shivar Garden Pimple Saudagar, Rahatani, Maharashtra 411017
Pune
MAHARASHTRA
4411017
India |
| Phone |
|
| Fax |
|
| Email |
aanchalgour221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish |
| Designation |
VP clinical research |
| Affiliation |
Sami-sabina group ltd |
| Address |
19/1 19/2 â… Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058
Bangalore
KARNATAKA
560058
India |
| Phone |
9900128263 |
| Fax |
|
| Email |
satish.g@sami-sabinagroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Satish |
| Designation |
VP clinical research |
| Affiliation |
Sami-sabina group ltd |
| Address |
19/1 19/2 â… Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058
KARNATAKA
560058
India |
| Phone |
9900128263 |
| Fax |
|
| Email |
satish.g@sami-sabinagroup.com |
|
|
Source of Monetary or Material Support
|
| Sami-Sabinsa Group Ltd
19/1, 19/2, I Main, II Phase
Peenya Industrial Area
Bangalore, India – 560058
|
|
|
Primary Sponsor
|
| Name |
Sami - Sabinsa group ltd |
| Address |
Sami-Sabinsa Group Ltd
19/1, 19/2, I Main, II Phase
Peenya Industrial Area
Bangalore – 560058
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Sonal Shendkar |
Skinovate Laser and cosmetic center |
Skinovate laser and cosmetic center Office No. 302 and 303, Third Floor, ‘Royal Avenue’, Survey No.18 Hissa No.11/6, Next to Hotel ‘Shivar Garden Pimple Saudagar, Rahatani, Maharashtra 411017
Pune
MAHARASHTRA |
07385126865
aanchalgour221@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Skinovate Independent ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions
2. Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
3. Subjects who have normal, dry, oily, combination (mixed) type of skin types.
5. Fitzpatrick photo type I to VI skin type.
6. Willingness to participate as evidenced by voluntary written informed consent.
|
|
| ExclusionCriteria |
| Details |
Subjects presenting and/or satisfying any of the following criteria will not be included in this study:
1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
2. Women who are breast-feeding
3. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
4. Presence of Acne, TLC more than 10 (Inflammatory & Non-Inflammatory).
5. Active dermatosis (local or disseminated) might interfere with the results of the study.
6. Considered immune compromised.
7. History of photosensitivity, & or diseases aggravated or triggered by ultraviolet radiation.
8. Participants with dermatographism.
9. Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
10. Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit.
11. Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit
12. Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit.
13. Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation
14. Previous history of atopic dermatitis, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication
15. Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients including any component of the study product.
16. History of sensitization in a previous study.
17 Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit
18. Recent history (within the last years) of alcohol or other substance abuse
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the comedogenic potential of the Demelan Face Wash when applied topically under occlusive conditions on the skin of human subjects. |
Study duration is 28 Days. Follow-up every 3rd day till the end of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the comedogenic potential of the Demelan Face Wash when applied topically under occlusive conditions on the skin of human subjects. |
final outcome will measured at day 28. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
02/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study evaluates if Demelan Face Wash can clog pores (comedogenicity) by using a "follicular biopsy" test. This test involves applying the product on skin samples and examining their effects microscopically. Study Details: Objective: To assess whether Demelan Face Wash clogs pores when applied on human skin under specific conditions. Design: The face wash and controls are applied on a patch three times weekly over four weeks. Each patch is kept on the skin for 48-72 hours. Controls: The face wash is tested against isopropyl myristate (positive control) and saline (negative control), plus an untreated area. Sample Application: 25 mg/cm² of each sample is applied to the skin on the back of the participants, covered with a pad and micropore tape. Participants: 24 healthy adults will complete the study, with 3 additional for possible dropouts. The selected test area is between the shoulder blades and waist. The study will help determine if the face wash is safe for acne-prone skin. |