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CTRI Number  CTRI/2023/09/057974 [Registered on: 22/09/2023] Trial Registered Prospectively
Last Modified On: 28/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Study to evaluate the safety and efficacy of Skin care product for its non-comedogenic effect  
Scientific Title of Study   A prospective, open-label, 4 arm study to evaluate the safety and efficacy of Skin care product for its non-comedogenic effect in healthy male or female volunteers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/NCOM2/2023 Version Number: 1.0 Dated: 7-Aug-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka, India.

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka, India.

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka, India.

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Source of Monetary or Material Support  
Kreative Beauty Private Limited. 401, Building NO B1, Boomerang EquityBus II park CTS NO 4, Chandivali farm House, Sakinaka, Mumbai, Mumbai Suburban, Maharashtra 400072  
 
Primary Sponsor  
Name  Kreative Beauty Private Limited 
Address  401, Building NO B1, Boomerang EquityBus II park CTS NO 4, Chandivali farm House, Sakinaka, Mumbai, Mumbai Suburban, Maharashtra 400072  
Type of Sponsor  Other [Cosmetic Industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madan Mohan N T  Shetty’s Hospital  Plot no, 11 & 12, 12th F Main Rd, Room non 2 Department of medicine Ground floor Kaveri Nagar, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA 		 8065733349

drmadan1969@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shetty’s Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L708||Other acne,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hyphen All I Need Sunscreen SPF 50 PA  Dosage form: Semi Solid, Administration: Topical application, Direction for use: Take two finger lengths of the cream and apply it on the face in the morning and in the evening after washing the face and patting it dry. 
Intervention  Hyphen Barrier Care Cream - Normal to Dry Skin  Dosage form: Semi Solid, Administration: Topical application, Direction for use: Press the pump until the bottle is activated. Take 2 to 3 pumps and massage it on the skin in the morning and in the evening after washing the face and patting it dry. 
Intervention  Hyphen Barrier Care Cream - Oily Skin  Dosage form: Semi Solid, Administration: Topical application, Direction for use: Press the pump until the bottle is activated. Take 2 to 3 pumps and massage it on the skin in the morning and in the evening after washing the face and patting it dry. 
Intervention  Hyphen Golden Hour Glow Serum  Dosage form: Liquid, Administration: Topical application, Direction for use: Press the pump until the bottle is activated. Take 1 to 2 pumps and massage it on the skin in the morning and in the evening after washing the face and patting it dry. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Healthy Indian male/female healthy volunteers aged between 18-55 years.
2. Willing to give Informed Consent Form.
3. Mild to moderate Black heads on the face
4. Willing to complete the study assessments/questionnaires.
5. Willing to avoid usage of his/her own moisturizers and face
6. serum for at least one week before Commencement and during this study.

 
 
ExclusionCriteria 
Details  1. Pregnancy or breast feeding.
2. Patients with pre-existing severe systemic disease necessitating long-term medication.
3. Patients with mild to severe Anaphylaxis reactions.
4. Evidence of significant uncontrolled co-morbid disease.
5. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
6. Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
7. Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• To assess the safety and efficacy of the product for its non-comedogenic property
Following parameters will be evaluated:
• Appearance of black heads
• Improvement in Spot correction by improving the appearance of large pores
 		 Day 1 to Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire.  Day 1 to Day 28 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/09/2023 
Date of Study Completion (India) 11/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
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  

After obtaining the Ethics committee approval subjects will be asked to visit the site. Informed consent will be provided to the study volunteers, and after obtaining their consent, the subjects will be asked about their medical history and the Investigator or his/her designee will conduct a physical examination. Demographics and vital signs will be recorded. Subjects will be instructed to avoid using their own moisturizers and face serum for at least one week before commencement of this study. Once the subjects are found eligible they will be provided with the IP and advised to use on a daily basis. The product efficacy is determined by performing the assessments like Pore Indicator Test and assessment of Comedones (GAGS Score). Also Videodermoscopy will be done on Visit 1, Visit 2 and Visit 3 which will also help us in seeing the difference in the appearance of comedones. They also will be advised to fill the feedback questionnaires. The responses obtained will be statistically analyzed at the end of the trial to assess the safety and efficacy of the product.


 
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