FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/04/052018 [Registered on: 26/04/2023] Trial Registered Prospectively
Last Modified On: 09/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to evaluate blackheads and white heads  
Scientific Title of Study   Evaluation of comedogenicity potential of the investigational products by follicular biopsy test 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SAFE/SLNC/2023-01 Version 1.0 Dated 05 Apr 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Navya Annam 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Ground floor, Sensitivity Dept, no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor Bangalore

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  navya.annam@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Satish G 
Designation  Vice president 
Affiliation  Sami-Sabinsa Group Limited 
Address  19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  satish.g@clinworld.net  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr Satish G 
Designation  Vice president 
Affiliation  Sami-Sabinsa Group Limited 
Address  19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  satish.g@clinworld.net  
 
Source of Monetary or Material Support
Modification(s)  
Sami Sabinsa Group Ltd. 19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore – 560058  
 
Primary Sponsor
Modification(s)  
Name  Sami Sabinsa Group Ltd  
Address  19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore – 560058  
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Navya Annam  MS Clinical Research Pvt. Ltd  Ground floor, Sensitivity Dept, no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor Bangalore KARNATAKA
Bangalore
KARNATAKA 		 08041125934
08040917253
navya.annam@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male and female volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ar-Turmerone Cream  25 mg/cm2 of test products 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. Duration - 12 applications in 4 weeks. 
Comparator Agent  Negative control 1 (0.9% saline)  25 mg/cm2 of test products 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. Duration - 12 applications in 4 weeks. 
Comparator Agent  Negative Control 2 (Untreated)  No application 
Comparator Agent  Positive control (isopropyl myristate)  25 mg/cm2 of test products 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. Duration - 12 applications in 4 weeks. 
Intervention  Tvaksh Moisgaurd BTR  25 mg/cm2 of test products 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. Duration - 12 applications in 4 weeks. 
Intervention  Tvaksh Moisguard AC  25 mg/cm2 of test products 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. Duration - 12 applications in 4 weeks. 
Intervention  Tvaksh Moisguard DN   25 mg/cm2 of test products 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. Duration - 12 applications in 4 weeks. 
Intervention  Tvaksh Moisguard Ex  25 mg/cm2 of test products 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. Duration - 12 applications in 4 weeks. 
Intervention  Tvaksh Moisguard Sensi  25 mg/cm2 of test products 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. Duration - 12 applications in 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female subjects 18 to 65 years of age.
2. Subjects must be generally in good health as determined by a recent medical history which is on file with the investigator.
3. The ability of the subject to understand and sign a written informed consent form which must be obtained before treatment.
4. Willingness to avoid the use of topical products at the test sites during the study.
5. Subjects known to have comedogenic skin. Subjects who are prone to acne and skin break-outs.
6. Presence of micro-comedomes at the screening visit.
 
 
ExclusionCriteria 
Details  Subjects presenting and/or satisfying any of the following criteria will not be included in this study:
1. Individuals with an active or history of psoriasis, active allergic skin responses, or active eczema as determined by the initial paperwork. Individuals with a history of eczema will be allowed to the study, as long as they complete a supplemental consent form.
2. Individuals with sunburn, abrasions, scar tissue, or tattoos on the test sites, or diseases of the skin that might interfere with the evaluation made in this study or that expose study participants to unacceptable risks.
3. Women known to be pregnant, nursing, or planning to become pregnant during the study as determined by the initial paperwork.
4. Use of topical steroids and/or drugs at test sites as determined by the initial paperwork.
5. Current routine or frequent use of high doses of anti-inflammatory drugs for a defined medical condition as determined by medical history.
6. Individuals who had less than a two-week rest period since completion of any previous patch testing.
7. Individuals with uncontrolled metabolic diseases such as hypertension, hyperthyroidism, hypothyroidism, diabetes, etc.
8. Individuals who had a mastectomy in which axillary nodes were removed as determined by the initial paperwork.
9. Active or untreated skin cancer as determined by the initial paperwork.
10. Previous clinically determined allergic reaction or known sensitivities or allergies to personal care products of any type.
11. Individuals will be admitted to the study at the discretion of the Investigator based on medical history and findings of the pre-study interview and examination.
12. Subjects who are employed at CRO or with the sponsor
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the comedogenic potential of the test products when applied topically under
occlusive conditions on the skin of human subjects.
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
None  NA 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "13"
Final Enrollment numbers achieved (India)="13" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/05/2023 
Date of Study Completion (India) 01/06/2023 
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   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Subjects will be screened by the investigator for study inclusion/ exclusion criteria. Only subjects who meet the requirements of the inclusion criteria and are willing to sign an informed consent form will be enrolled into the study. 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 weekends. There will be a total of twelve (12) applications. The duration of the study is approximately 4 weeks. 25 mg/cm2 of test products 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 a webril pad are held securely to the skin on all sides wita porous, hypoallergenic tape. 
Close