CTRI

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CTRI Number

CTRI/2023/08/056777 [Registered on: 22/08/2023] Trial Registered Prospectively

Last Modified On:

18/08/2023

Post Graduate Thesis

Type of Trial

BA/BE

Type of Study

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A Double-Blind, Randomized, Placebo-controlled, Multicenter study of Azelaic acid 15% Gel for treatment of mild to moderate papular-pustular acne of the facial area or facial rosacea.

Scientific Title of Study

A Double-Blind, Randomized, Parallel Group, Placebo-controlled, Multicenter study to evaluate the bioequivalence (Clinical equivalence) of test formulation Azelaic acid 15% Gel of Kusum Healthcare Pvt. Ltd., India with Skinoren 15 % Gel (Azelaic acid) Leo Pharma, EU among Subjects with mild to moderate papular-pustular acne of the facial area or facial rosacea.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
Azelaic acid-01, Version : 01, Dated : 09 Feb 2022	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Mr Hari Emmadi
Designation	Manager
Affiliation	Vayam Research Solutions Limited
Address	Next to zodiac party plot behind shaligram lake view opp AUDA garden behind vaishnodevi temple khoraj gandhingar Gujarat Gandhinagar GUJARAT 382421 India Gandhinagar GUJARAT 382421 India
Phone	9703089558
Fax
Email	hari.e@vayamresearch.net

Details of Contact Person
Scientific Query

Name	Mr Hari Emmadi
Designation	Manager
Affiliation	Vayam Research Solutions Limited
Address	Next to zodiac party plot behind shaligram lake view opp AUDA garden behind vaishnodevi temple khoraj gandhingar Gujarat Gandhinagar GUJARAT 382421 India Gandhinagar GUJARAT 382421 India
Phone	9703089558
Fax
Email	hari.e@vayamresearch.net

Details of Contact Person
Public Query

Name	Mr Hari Emmadi
Designation	Manager
Affiliation	Vayam Research Solutions Limited
Address	Next to zodiac party plot behind shaligram lake view opp AUDA garden behind vaishnodevi temple khoraj gandhingar Gujarat Gandhinagar GUJARAT 382421 India Gandhinagar GUJARAT 382421 India
Phone	9703089558
Fax
Email	hari.e@vayamresearch.net

Source of Monetary or Material Support

Kusum Healthcare Private Limited

Kusum Healthcare Pvt. Ltd. SP 289 (A) RIICO Industrial Area, Chopanki, Bhiwadi, Dist.-Alwar Rajasthan-301019, India

Primary Sponsor

Name	Kusum Healthcare Private Limited
Address	D-158A Okhla Industrial Area, Phase 1 New Delhi - 110020
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 R Kothandaramasamy	Madurai Medical College and Govt. Rajaji Hospital,	Madurai Medical College and Govt. Rajaji Hospital, Madurai Medical College Panagal Road, Madurai, Chennai Tamil Nadu - 625020 Department of Dermatology, Room No: 11 Madurai TAMIL NADU	9789328238 ranjith@leszarians.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Madurai Medical College and Govt. Rajaji Hospital Madurai Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: L00-L99\|\|Diseases of the skin and subcutaneous tissue,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Azelaic acid	15 % Gel, applied twice a day morning and evening for 12 weeks, Local application
Comparator Agent	Skinoren 15 % Gel (Azelaic acid)	15 % Gel, applied twice a day morning and evening for 12 weeks, Local application

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Male or non-pregnant female aged ? 18 years with a clinical diagnosis of mild to moderate papular-pustular acne of the facial area OR facial rosacea Subject willing to minimize external factors that might trigger acne/rosacea flare- ups (e.g., spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds and alcoholic beverages Subject must be in general good health and free from any clinically significant disease other than acne/rosacea, that might interfere with the study Willing to provide written informed consent for participation in the study and adhere to the protocol requirements Subjects who agree to return for follow-up visits

ExclusionCriteria

Details

Pregnant or lactating or planning to become pregnant during the
study period
Presence of any skin condition on the face that would interfere with
the
diagnosis or assessment of acne/rosacea
Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that
would
interfere with diagnosis or assessment of acne/rosacea
History of hypersensitivity or allergy to study drugs or any other
component
of the formulation
Use within 6 months prior to Baseline of oral retinoids or therapeutic
vitamin
A supplements of greater than 10,000 units/day
Use for less than 3 months prior to Baseline of estrogens or oral
contraceptives;
use of such therapy must remain constant throughout the study
Use within 2 weeks prior to baseline of
1) topical corticosteroids,
2) topical antibiotics or
3) topical medications for acne/rosacea (e.g., metronidazole, azelaic
acid)
Subjects with moderate or severe rhinophyma, dense telangiectases,
or plaquelike
facial edema

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pharmacy-controlled Randomization

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
To Evaluate the bioequivalence (Clinical equivalence) of test formulation Azelaic acid 15% Gel at week 12	To Evaluate the bioequivalence (Clinical equivalence) of test formulation Azelaic acid 15% Gel at week 12

Secondary Outcome

Outcome	TimePoints
To evaluate the safety of Azelaic acid 15% Gel over 12 weeks	Week 12

Target Sample Size

Total Sample Size="330"
Sample Size from India="330"
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

Phase 3

Date of First Enrollment (India)

30/08/2023

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="4"
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

The primary purpose of this study is to evaluate the bioequivalence (Clinical equivalence) of test formulation Azelaic acid 15% Gel of Kusum Healthcare Pvt. Ltd., India With Skinoren 15 % Gel (Azelaic acid) Leo Pharma, EU among Subjects with mild to moderate papular-pustular acne of the facial area or facial rosacea.

This is a 12 week study and the primary end point of this study will be assessed through 12 weeks. This will allow for assessment of efficacy at a time point for which efficacy data of the approved product is available. The placebo-controlled study design was chosen to demonstrate the efficacy of the test product in adult subjects with mild to moderate papular-pustular acne of the facial area or facial rosacea to placebo. Due to the nature of rosacea and the outcome measures for the primary and the secondary endpoints used, a placebo arm is necessary for reliable results on efficacy and safety.

The reference product, Skinoren Gel is already available in the market from 1989 and its safety and efficacy is profile is well established. Additonally, the inclusion of a placebo group is in accordance with health authority guidelines. A placebo control arm is recommended to demonstrate that the test product and reference product are active and as a parameter that the study is sufficiently sensitive to detect differences between products.