| CTRI Number |
CTRI/2024/04/065411 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to assess the test product Kogigold cream is not known to produce any pimples/Acne after its application of Human skin. |
|
Scientific Title of Study
|
Evaluation of comedogenicity potential of the Kojigold cream 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 |
Dr Shendkar Sonal Mahadev |
| Designation |
Consultant Dermatologist |
| Affiliation |
Skinovate Laser & Cosmetic Surgery center |
| Address |
3rd Floor, Clinical Research Department
302, 303 Royal Avenue building 3rd floor Near Shivar garden Restaurant Pimple Saudagar, Pune
Pune
MAHARASHTRA
411027
India |
| Phone |
9960178611 |
| Fax |
|
| Email |
Shendkar.sonal82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami Sabinsa Group Ltd |
| Address |
1st Floor, Clinical Research Department.
19/1 19/2 I Main II Phase Peenya Industrial Area Bangalore
Bangalore
KARNATAKA
560058
India |
| Phone |
8068527776 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami Sabinsa Group Ltd |
| Address |
1st Floor, Clinical Research Department
19/1 19/2 I Main II Phase Peenya Industrial Area Bangalore
Bangalore
KARNATAKA
560058
India |
| Phone |
8068527776 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
|
Source of Monetary or Material Support
|
| Sami-Sabinsa Group Ltd & Alkem Laboratories Ltd
1st Floor, Clinical Research Department
19/1 19/2 I Main II Phase Peenya Industrial Area Bangalore-560058, India. |
|
|
Primary Sponsor
|
| Name |
Sami-Sabinsa Group Ltd |
| Address |
19/1, 19/2, I Main, II Phase Peenya Industrial Area, Bangalore – 560058 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Alkem Laboratories Ltd |
G/4, Empire Complex,414,Senapati Bapat Marg, Lower Parel, Mumbai – 400013. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonall |
Skinovate Laser & Cosmetic Surgery center |
Office no. 303 Third floor, Clinical Research Department, Royal avenue Survey no 18 Hissa no. 11 6 Next to Hotel Shivar garden Pimple Saudagar Rahatani Taluka Haveli Pune
Pune
MAHARASHTRA |
9960178611
Shendkar.sonal82@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 |
To determine the comedogenic potential of the Kojigold cream when applied topically under occlusive conditions on the skin of human subjects. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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.
4. Fitzpatrick photo type I to IV skin type
5. Willingness to participate as evidenced by voluntary written informed consent
|
|
| ExclusionCriteria |
| 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.
4. Fitzpatrick photo type I to IV skin type
5. Willingness to participate as evidenced by voluntary written informed consent
Exclusion Criteria:
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. Presence of Acne, TLC more than 10 (Inflammatory & Non-Inflammatory).
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 patch 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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comedogensis:
Upon completion of the above-described counting procedure, the ratio will be calculated as.
Number of comedones/ Number of follicles.
|
Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20, Day 22, Day 24, Day 26, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency and severity of Adverse Events |
Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20, Day 22, Day 24, Day 26, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
19/04/2024 |
| 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="28" |
|
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
|
To determine the comedogenic potential of the Kojigold cream when applied topically under occlusive conditions on the skin of human subjects. Each test material will be applied three (3) times a week for four weeks. The application will be done every alternate day, and the occlusion should be maintained for 48 hours on weekdays and 72 hours on weekend. There will be a total of twelve (12) applications. The duration of the study is approximately 4 weeks. 25 mg/cm2 of test product and control will be pipetted out on the demarked test site of 4X4 cm2 and spread uniformly. A webril pad will be applied on top of it and will be completely occluded with the micropore tape. One test site is kept as untreated control (sham control) on which an empty webril pad will be applied. Micropore tape will be used to hold the Webril pad tightly. Occlusive patches with webril pad are held securely to the skin on all sides with a porous, hypoallergenic tape a) There will be three applications per week. Each application will be done on the test site via PDP/syringe. The test sites, each measuring 4x4cm are covered with a piece of non-absorbing cotton cloth (i.e., Curity or Webril). The patches are closely secured to the skin by occlusive tape (i.e., adhesive Blenderm or Dermalite II). b) The procedure is repeated every alternate day until three applications per week is accomplished for a total of four weeks for occlusive conditions. Patches are removed after 48hours of exposure and once weekly after 72 hours of exposure. On removal all sites are cleaned and evaluated for any overt signs of irritation prior to repatching. c) At the end of 4 weeks, follicular biopsy is performed at each site by placing a drop of cyanoacrylate glue on a microscope slide and holding it against the skin on the exposed site for 1 minute. The slide is gently removed from the skin, after extracting any microcomedones present at the site. Upon curing, the test slide is rapidly but accurately removed to protect the integrity of the biopsy. Slides are examined under a microscope and the number of follicles and microcomedones (if any) are counted per square cm. An optical micrometer is employed to measure the number of microcomedones and follicles to provide a tangible reference for evaluation. The counts are then totalled and averaged for comparison.Assessments Local Intolerance Monitoring In case of localized skin irritation, it will be recorded in the Local Intolerance form by a dermatologist. Comedogensis: Upon completion of the above-described counting procedure, the ratio will be calculated as. Number of comedones/ Number of follicles. Nu |