| CTRI Number |
CTRI/2023/06/054208 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Evaluate Safety, Efficacy of Topical 1% AKP-11 in Atopic Dermatitis Participants. |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double Blind, Placebo-controlled, Two-arm, Phase II Clinical study to evaluate Safety, Tolerability and Efficacy of Topical 1% AKP-11 in Atopic Dermatitis Participants. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/APPL/0315/001, Version: 02, Dated: 07 Jan 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Perumal M |
| Designation |
Principal Investigator |
| Affiliation |
Panimalar Medical College Hospital & Rersearch Institute |
| Address |
Room no3 dept dermatology Varadharajapuram, Chennai Outer Ring Rd, Poonamallee, Chennai.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9629048549 |
| Fax |
|
| Email |
perumd88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director Operations |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura.
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director Operations |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura.
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Stellence Pharmscience Pvt Ltd.
No 456, Road 3, Industrial Area,
Jigani, Bangalore 560105, India
|
|
|
Primary Sponsor
|
| Name |
Akaal Pharma Pty Ltd |
| Address |
Thomas Cherry Building,
#301 E & F Chemistry Department,
La Trobe University, Bundoora,
VIC – 3086, Australia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Madan |
Ajanta Hospital & IVF Centre |
765 ABC Complex,
Kanpur Road, Alambagh, Lucknow, UP-226005
Kanpur Nagar
UTTAR PRADESH |
9838001239
91522410107
amitmadan_2000@yahoo.com |
| Dr Rajeev Agarwal |
Atharva Multispeciality Hospital and Research Centre |
H-4/comm-2, Construction Div-21, UP Avas Vikas Parishad, Sector-E, 226003
Lucknow
UTTAR PRADESH |
9415080604
drrajeeva1@rediffmail.com |
| Dr K Vijay Babu |
Happy Health Clinic |
#7/26, Anna Nagar, 2nd Street, Saradha College Road, 636007
Salem
TAMIL NADU |
9944293939
drvijaymd@hotmail.com |
| Dr Ipsa Pandya |
Nirogyam ICU and Multispeciality Hospital |
201 - 204, Nirgun One Complex, beside Orchid Exotica, near Makarba Underpass, Makarba, Ahmedabad - 380051, Gujarat.
Ahmadabad
GUJARAT |
9904865577
dr.ipsapandya@gmail.com |
| Dr Bhumi Patel |
Noble Hospital |
329-330, South Bopal Trade Centre, South Bopal,Ahmedabad,
Gujarat -380051.
Ahmadabad
GUJARAT |
9825700739
dr.bhumipatel01@gmail.com |
| Dr Perumal M |
Panimalar Medical College Hospital & Rersearch Institute |
Room no. 03 Dept. Dermatology Varadharajapuram, Chennai Outer Ring Rd, Poonamallee, Chennai - 600123.
Thiruvallur
TAMIL NADU |
9629048549
perumd88@gmail.com |
| Dr Srinivas K |
Udhbhava Hospital |
#114, 100 feet ring road, Ittamadu, Banashankari 3rd stage, Bengaluru-560085
Bangalore
KARNATAKA |
9739006755
srinivaskonappalli4644@gmail.com |
| Dr Mona Ketan Borole |
Vedant Skin and Cosmetic Clinic |
Khadke & Chaudhari Constructions Building Opp Bhaskar Market Gate, MJ College Road, Jalgaon, Maharashtra 425001
Jalgaon
MAHARASHTRA |
9730892190
drmonaborole@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Balaji Independent Ethics Committee |
Approved |
| ICE-ARC lnstitutional Ethics Committee |
Approved |
| Institutional Ethics Committee, Atharva Multispeciality Hospital and Research centre |
Approved |
| Panimalar Medical College Hospital & Research Institute - Institutional Human Ethics Committee (PMCHRI-IHEC) |
Approved |
| Sangini hospital ethics committee |
Approved |
| Sangini hospital ethics committee |
Approved |
| Sri Durgamba Independent Ethics Committee |
Approved |
| Yashodhan Hospital Institutional Ethics Committee, Jalgaon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% AKP-11 ointment |
dose: 1%,
dosage form: ointment,
route: topical,
frequency: 1-7 days (TID), 7-14 days(BID),
treatment duration: 14 days,
sudy duration: 21 days.
|
| Comparator Agent |
Placebo |
dose: NA
dosage form: ointment,
route: topical,
frequency: 1-7 days (TID), 7-14 days(BID),
treatment duration: 14 days, sudy duration: 21 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with Atopic Dermatitis as per Hanifin and Rajika method will be taken in the study.
2. Participants with Diagnosis of Mild to Moderate Atopic Dermatitis (AD) condition as per Scoring of Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) will be included in the study.
3. Participants with at least one Atopic Dermatitis spot with baseline score of pruritus as high moderate to severe itch (VAS ≥6cm) with average pruritus of (VAS ≥6cm) over 3 consecutive days prior to baseline visit.
4. Participants who will be able to provide written informed consent prior to the performance of any study specific procedures. |
|
| ExclusionCriteria |
| Details |
1. Participants with history of allergy or hypersensitivity to any of the ingredients such as AK-119 free base, Propylene glycol, Stearic acid, Paraffin oil, Cetyl alcohol, Petrolatum jelly and Glyceryl monostearate.
2. Participants with any skin condition other than Atopic dermatitis, such as cutaneous infections, skin cancer, significant sun damage or an inherited skin disorder that in the opinion of the Investigator could interfere with the evaluation of the trial medication.
3. Participants suspected with COVID-19 symptoms.
4. Topical treatment within 2 weeks prior to commencement of study treatment including: topical corticosteroids; topical calcineurin inhibitor, antihistamine or any other topical treatments that in the opinion of the investigator could modify disease activity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Percentage change in Scoring of Atopic Dermatitis (SCORAD).
2. Percentage change in Eczema Area and Severity Index (EASI).
3. Proportion of participants with an improvement of pruritus on VAS scale. |
Baseline (Day 1) to EOT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of participants with an Investigator Global Assessment (IGA) success defined as:
• ≥2 point improvement
2. Safety of AKP-11 ointment. |
Baseline (Day 1) to EOT |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2 |
|
Date of First Enrollment (India)
|
28/06/2023 |
| 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="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
STUDY TITLE: A Multicenter, Randomized, Double Blind, Placebo-controlled, Two-arm, Phase II Clinical study to evaluate Safety, Tolerability and Efficacy of Topical 1% AKP-11 in Atopic Dermatitis Participants.
Objective: To determine the safety, tolerability, and efficacy of topical 1% AKP-11 ointment when applied in Atopic Dermatitis Participants and to demonstrate the active treatment over placebo.
End points:
| Primary Endpoints 1. Percentage change in Scoring of Atopic Dermatitis (SCORAD) from baseline (Day 1) to EOT. 2. Percentage change in Eczema Area and Severity Index (EASI) from baseline (Day 1) to EOT. 3. Proportion of participants with an improvement of pruritus on VAS scale from baseline (Day 1) to EOT. Secondary Endpoints 1. Proportion of participants with an Investigator Global Assessment (IGA) success defined as: · ≥2 point improvement from baseline (Day 1) at Day 7 and 14. 2. Safety of AKP-11 ointment Number of subjects: A total of 150 participants will be randomized in 1:1 proportion as 75:75 participants in each arm (1% AKP-11 and Placebo respectively) Study Duration: 21 Days | |