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CTRI Number  CTRI/2024/12/078205 [Registered on: 17/12/2024] Trial Registered Prospectively
Last Modified On: 16/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To Test the effect 6 in 1 Acne Cream in treating Patients with Acne  
Scientific Title of Study   A Prospective, Single Arm, Clinical Study to Evaluate the Efficacy and Safety of Acne Moisturizer 6 in 1 Acne Control Cream Formula in Patients with Acne Vulgaris 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ACNE 6IN1/25/24, Version: 1.0 Date: 08.10.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Roshany 
Designation  Dermatologist 
Affiliation  DK Elite Health Care Centre 
Address  Room no.2, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004

Pondicherry
PONDICHERRY
605004
India 
Phone  09943805988  
Fax    
Email  roshanysakthibalan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roshany 
Designation  Dermatologist 
Affiliation  DK Elite Health Care Centre 
Address  Room no.2, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004

Pondicherry
PONDICHERRY
605004
India 
Phone  09943805988  
Fax    
Email  roshanysakthibalan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar 
Designation  Director 
Affiliation  KI3 PRIVATE LIMITED 
Address  No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai

Chennai
TAMIL NADU
600 044
India 
Phone  09003109416  
Fax    
Email  kai3.mrg@gmail.com  
 
Source of Monetary or Material Support  
Trubliss International Ground Floor, Shop No 16, Plot No-3D Wing, Seamist Building, Shree Gajanan CHS, RSC-25, Charkop Sector-8, Kandivali West, Mumbai-400067  
 
Primary Sponsor  
Name  Trubliss International  
Address  Ground Floor, Shop No 16, Plot No-3D Wing, Seamist Building, Shree Gajanan CHS, RSC-25, Charkop Sector-8, Kandivali West, Mumbai-400067  
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 
Dr Roshany  DK Elite Health Care Centre  DK Elite Health Care Centre, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004
Pondicherry
PONDICHERRY 		 09843591097

roshanysakthibalan@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  ACNE MOISTURIZER 6 IN 1 ACNE CONTROL CREAM FORMULA  Glycerine, Niacinamide, Curcuminoid, Canabis sativa leaf Usage: Apply 1.0 gm of the product dot-wise on your face twice daily for 30 days, spreading gently with your fingers as directed by your dermatologist. 
Comparator Agent  Not applicable- Single arm study  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 isotretinoine 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 or 1 on GAAS Percentage of patients with minimal or no acne on the GAAS scale.
2.Change in Inflammatory Lesions
3.Change in Noninflammatory Lesions Change in the number of noninflammatory lesions from baseline.
4.Change in Total Lesion Counts Overall change in facial lesion count from baseline.
5.Microbiological Swab Swab taken from acne lesion site at baseline and post-study (day 15 or 30).
6.Percentage Reporting "Very Good" or "Excellent" on ASIS Item 10: Percentage of patients rating acne symptom impact as "Very Good" or "Excellent.
7.Overall Improvement in Skin Health.
8. Burning, Itching, Tingling, Stinging Scores.
9.Sebumetric Analysis.
10.Corneometer Analysis
11.Dermatology Life Quality Index
12.Ease of Use.
13.Pre and Post Study Photographic Assessments  		 DAy 0, day 15 and day 30 
 
Secondary Outcome  
Outcome  TimePoints 
•Patient and Investigator Feedbacks will be obtained
•Adverse event monitoring
 		 DAy 0, day 15 and day 30 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   31/12/2024 
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="6"
Days="0" 
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  

Study Summary

Objectives:

  1. To evaluate the efficacy of ACNE MOISTURIZER 6 IN 1 ACNE CONTROL CREAM FORMULA in reducing acne.
  2. To assess the safety of ACNE MOISTURIZER 6 IN 1 ACNE CONTROL CREAM FORMULA.

Eligibility Criteria:

  • Inclusion Criteria:
    1. Healthy male or female subjects aged 18-45 years.
    2. Healthy skin in the test areas. Participants will apply 1.0 gm of the test product twice daily for 30 days, using only fingers to spread the product in an outward direction without rubbing it into the skin.
    3. Subjects willing and able to follow the study guidelines and a fixed schedule.
    4. Ability to give informed consent for participation.
    5. Subjects with good general health and mental condition.
    6. At least 10 inflammatory lesions present.
    7. Oily skin on the face.
    8. Subjects must visit the clinical facility for follow-ups at day 15 and day 30, with additional visits as needed.
  • Exclusion Criteria:
    1. Pregnancy or breastfeeding.
    2. Severe acne or more than two nodular lesions.
    3. Changes in oral contraception method within 3 months prior to the study.
    4. Acne hormonal treatment less than 6 months prior to the study.
    5. Oral isotretinoin treatment within 1 month of the study.
    6. Topical acne treatment within 90 days before the study.
    7. Aesthetic treatments (e.g., laser, peeling) within 6 months prior to the study.
    8. Antibiotic treatment within the last 4 months.
    9. Simultaneous participation in other clinical studies involving the same test sites.
    10. Hypersensitivity to any ingredient of the test product.
    11. Patients on steroid or other immunomodulatory therapy.

Participants will apply the test product twice daily and visit the clinical facility for follow-up evaluations to assess acne reduction and skin safety.  

  1. Percentage of Patients with a Score of 0 or 1 on GAAS: Percentage of patients with minimal or no acne on the GAAS scale.
  2. Change in Inflammatory Lesions: Change in the number of inflammatory lesions from baseline.
  3. Change in Noninflammatory Lesions: Change in the number of noninflammatory lesions from baseline.
  4. Change in Total Lesion Counts: Overall change in facial lesion count from baseline.
  5. Microbiological Swab: Swab taken from acne lesion site at baseline and post-study (day 15 or 30).
  6. Percentage Reporting "Very Good" or "Excellent" on ASIS Item 10: Percentage of patients rating acne symptom impact as "Very Good" or "Excellent."
  7. Overall Improvement in Skin Health: Skin health improvement measured on a 5-point scale.
  8. Burning, Itching, Tingling, Stinging Scores: Scores for any skin reactions (0-3 scale).
  9. Sebumetric Analysis: Sebum level measurements at various time points.
  10. Corneometer Analysis for Moisturization: Moisturization levels assessed at multiple times.
  11. Dermatology Life Quality Index (DLQI): Quality of life impact assessed using the DLQI questionnaire.
  12. Ease of Use: Patient feedback on product texture and fragrance (1-4 scale).

Pre and Post Study Photographic Assessments: Photos taken before and after the study to assess skin condition

·       Patient and Investigator Feedbacks will be obtained, Adverse event monitoring


 
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