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CTRI Number  CTRI/2024/05/067758 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 20/05/2024
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 on Human skin.  
Scientific Title of Study   An open label study to evaluate the Anti-Acne potential of the Kogigold cream in reduction of inflammatory and non-inflammatory acne lesion on oily & or mixed skin types of volunteers.”. 
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 and Cosmetic Surgery center 
Address  Skinovate Laser and Cosmetic Surgery Centre 3rd Floor Clinical Research Department 302 and 303 Royal Avenue building 3rd floor Near Shivar garden Restaurant Pimple Saudagar Pune

Pune
MAHARASHTRA
411027
India 
Phone  9665041290  
Fax    
Email  drsonal.skinovate@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shendkar Sonal Mahadev  
Designation  Consultant Dermatologist  
Affiliation  Skinovate Laser and Cosmetic Surgery center 
Address  Skinovate Laser and Cosmetic Surgery Centre 3rd Floor Clinical Research Department 302 and 303 Royal Avenue building 3rd floor Near Shivar garden Restaurant Pimple Saudagar Pune

Pune
MAHARASHTRA
411027
India 
Phone  9665041290  
Fax    
Email  drsonal.skinovate@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shendkar Sonal Mahadev  
Designation  Consultant Dermatologist  
Affiliation  Skinovate Laser and Cosmetic Surgery center 
Address  Skinovate Laser and Cosmetic Surgery Centre 3rd Floor Clinical Research Department 302 and 303 Royal Avenue building 3rd floor Near Shivar garden Restaurant Pimple Saudagar Pune

Pune
MAHARASHTRA
411027
India 
Phone  9665041290  
Fax    
Email  drsonal.skinovate@gmail.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  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 shushil chaudhary   Skinovate Laser and 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 		 9665041290
-
sushilrc.chaudhary@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  To assess the Anti-Acne potential of the Kogigold cream in reduction of the inflammatory (Papules Pustules) and non-inflammatory (Open Closed Comedons) lesion count  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Male and female subjects aged 18 to 45 with mild to moderate Acne Vulgaris. Acne on the face, either non-inflammatory lesions (i.e., open and closed comedones) AND inflammatory lesions (i.e., papules and pustules).
2. Subjects with facial acne having IGA grade 1 and 2
3. Subjects with Oily & or Mixed type of facial skin.
4. 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
5. Willingness to participate as evidenced by voluntary written informed consent
6. Subject are willing to comply with study instructions and return to the clinic for required visits.
 
 
ExclusionCriteria 
Details  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy
3. Subject has greater than two (2) facial nodules.
4. Subject has nodulocystic acne
5. Subject is currently enrolled in an investigational drug or device study OR has been treated with an investigational product or device within 30 days prior to the initiation of treatment (Baseline)
6. Subject has facial hair especially full-grown beard that could interfere with the study assessments in the opinion of the investigator.
7. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
8. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
9. Patients exhibiting acute or chronic dermatological, medical, and/or physical conditions which would preclude application of the test materials and/or influence the outcome of the study.
10. Patients who must use oral corticosteroids and/or oral immunosuppressive drugs (steroid inhalers or decongestant nose drops and/or eye drops are permitted).
11. Active dermatosis (local or disseminated) that might interfere with the results of the study.
12. History of diseases aggravated or triggered by ultraviolet radiation.
13. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Mean percent change from baseline to week 4 in the inflammatory (papules and pustules) lesion count
2. Mean percent change from baseline to week 4 in the Non-inflammatory (open and closed comedones) lesion count.
 		 Day 1, Day 7, Day 14, Day 21, and Day 28
 
 
Secondary Outcome  
Outcome  TimePoints 
1) Mean percent change from baseline to week 2/(D-14) in the inflammatory (papules and pustules) lesion count
2) Mean percent change from baseline to week 2/(D-14) in the Non-inflammatory (open and closed comedones) lesion count.
3) No. of patients showing improvement in the IGA score.
4) Frequency and severity of Adverse Events
5) The incidence of treatment-emergent adverse events
6) Application site reaction assessments
7) Tolerance evaluation scale
 		 week-2 9( Day 14)  
 
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)   03/06/2024 
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  

An open label study to evaluate the Anti-Acne potential of Kogigold cream in reduction in the inflammatory and non-inflammatory lesion count on face.

Following provision of informed consent and completion of all screening assessments, eligible subjects will be enrolled in the study.

Study will be conducted over a period of 28 days for each subject, subject will apply anti acne cream  twice daily with the gap of 6-8 hours between two successive applications, till the investigator inform subject to stop application or the study ends for the maximum period of 28 days.

Subject will apply Anti Acne cream  on full face, facial skin will be evaluated by Dermatologists for reduction in Total Lesion Count (TLC) on day 1, 7, 14, 21 & Day 28. 

Safety Assessment- for any signs of irritation (redness/inflammation, itching or irritation).

Subjects will be assessed for frequency and severity of adverse events 
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