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CTRI Number  CTRI/2023/09/058098 [Registered on: 27/09/2023] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Effect Of Glaze 5-In-1 Acne Control gel to treat ACNE(pimples).  
Scientific Title of Study   A Prospective, Single Arm, Clinical Study To Evaluate The Efficacy And Safety Of Glaze 5-In-1 Acne Control Formula In Patients With Acne Vulgaris  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ACNEGEL/10/23 ver 1.0 Date : 28-06-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR BRINDA G DAVID 
Designation  Consultant Dermatologist 
Affiliation  Brindas Skin Clinic 
Address  No 265, Bussy Street near kamban kalaiarangam above alpha clinic Puducherry

Pondicherry
PONDICHERRY
605001
India 
Phone  9751628254  
Fax    
Email  docbrinz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan MD 
Designation  Consultant and CI 
Affiliation  Thirumalai medical Centre, ki3 
Address  Thirumalai medical Centre, Room no. 1, Thirumalai medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar  
Designation  CEO 
Affiliation  KI3, CRO 
Address  KI3 Room no.1, Ki3 office, Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9003109416  
Fax    
Email  drgayathri@ki3services.com  
 
Source of Monetary or Material Support  
Pontika Aerotech Ltd.Johron, Himachal Pradesh 173025 
 
Primary Sponsor  
Name  Pontika Aerotech Limited 
Address  Pontika Aerotech Limited Vill Johron,PO Puruwala,Nahan Road, Paonta Sahib,Dist-Srimour,Himachal Pradesh - 173001 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
DrBrinda G David  Brinda’s Skin Clinic  No 265, Bussy Street near kamban kalaiarangam above alpha clinic Puducherry-605001
Pondicherry
PONDICHERRY 		 9751628254

docbrinz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHIQUE DE LA NATURE ASSOCIATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GLAZE 5-IN-1 ACNE CONTROL FORMULA   To be Applied topically morning and night by taking adequate amount to cover the lesion . For 4 weeks.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details 
1. Healthy male or female subjects in the age group of 18-45 years
2. Healthy skin in the test areas;
3. Subjects willing and capable to follow the study rules and a fixed schedule;
4. Ability of giving consent for participation in the study;
5. Subjects with good health in general and good mental condition;
6. Subjects who present at least 10 inflammatory lesions;
7. Oily skin on the face
 
 
ExclusionCriteria 
Details  1. Pregnancy or breastfeeding;
2. Subjects who present severe acne;
3. Subjects who present more than two nodular lesions;
4. Subjects who changed their oral contraception method up to three months before the study beginning;
5. Subjects who did acne hormonal treatment less than 6 months before the study;
6. Subjects who did oral isotretinoïne treatment less than 1 month before the study;
7. Subjects who did topical acne treatment less than 90 months before the study;
8. Subjects who did aesthetic treatment less than 6 months before the study (like laser and peeling);
9. Subjects who did treatment with antibiotics within the last 4 months;
10. Simultaneous participation in different studies from external research institutes on the same test sites
11. Hypersensitivity to any of the ingredients of the test product.
12. Pregnant or lactating women
13. Patients on steroid therapy or any other immunomodulatory agents
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5- point Global Acne Assessment Score (GAAS)
2) Change From Baseline in Inflammatory Facial Lesion Counts
3) Change From Baseline in Noninflammatory Facial Lesion Counts
4) From Baseline in Total Lesion Counts
5) Microbiological Swab from the Acne lesion site will be taken
6) Instrumental Assessment:
-Sebumetric analysis (Baseline, 1Hr, 2Hr, 6Hr, 12Hr and 24Hrs post application) and also post study at day 30.
- Corneometer analysis for skin Moisturization (Baseline, 1Hr, 2Hr, 6Hr, 12Hr and 24Hrs post application)
7) Dermatology Life Quality Index (DLQI) questionnaire
 		 Day 0, 15 and 30 
 
Secondary Outcome  
Outcome  TimePoints 
Patient and Investigator Feedbacks will be obtained
Adverse event monitoring 		 BAseline, Day 0, Day 15,Day 30 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/10/2023 
Date of Study Completion (India) 01/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
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   Study Procedure: 

The study who fulfilled the inclusion and exclusion criteria will be enrolled in the study . 30 Participants will be randomized in to a single group.

The application of the product will be done at site on each day of assessment throughout the study period by the subject. Subject will wash their test area with a water prior to the application. After pat dry, the test product will be applied on the acne lesions ( approximately 8-12 hours apart) twice daily throughout the study duration. After application, the subject should not wash their test site for at least 2 hours with water or any other product. Subjects will avoid unnecessary sun exposure immediately after morning product application. Take approx 1.0 gm quantity of test product on tip of index finger. Apply dot wise on whole face and then lightly spread test product using only fingers in outward direction. Ensure that you do not rub the product in to your skin. Apply the product twice daily in morning and evening on whole face for the period of 30 days 
(As directed by the Dermatologist). Subject will be asked to visit Clinical Facility for their follow up at the end of 15 and 30 days and any other additional visits if needed.

Primary and secondary outcome

1) Global Acne Assessment Score (GAAS)
2) Change from baseline in Inflammatory facial Lesion counts
3) Change from Baseline in Noninflammatory Facial Lesions Counts
4) Microbiological swabs from Acne Lesion Site on baseline and Post study ( day 15 or day 30 based on healing)
5) Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale ( ASIS)
6) Overall Improvement of skin health
7) Scoring in terms of Itching
8) Instrument Analysis:  Sebumetric Analysis, Corneometer Analysis
9) DLQI
10) Ease of use
11) Pre and Post study Photographic assessments



 
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