| CTRI Number |
CTRI/2019/05/019277 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
18/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare test and reference products of permethrin 5% cream use for treatment of scabis for its effectiveness and safety. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Multicentric, Parallel group, comparative clinical study of Permethrin 5% cream of Morningside Healthcare Limited, UK (Test) vs Permethrin 5% cream of Medgenix Benelux NV (Belgium) (Reference) for the treatment of scabies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECTS/19/002, Version 01, Dated 18 Feb 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
|
Source of Monetary or Material Support
|
| Morningside Healthcare Ltd
Morningside House
Unit C, Harcourt Way
Meridian Business Park
Leicester
LE19 1WP
|
|
|
Primary Sponsor
|
| Name |
Morningside Healthcare Ltd |
| Address |
Morningside House
Unit C, Harcourt Way
Meridian Business Park
Leicester
LE19 1WP |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Montu Deka |
Downtown Hospital |
517, 5th floor, 1st building, Downtown Hospital, Dispur, GS Road, Guwahati-781006
Kamrup
ASSAM |
9435033901
drmontu_deka@yahoo.com |
| Dr Usha Naraindas Khemani |
Gokuldas Tejpal Hospital, Grant Government Medical College, Sir J.J Group of Hospital |
Department of Dermatology, First floor, Nr. Police commissioner office, forte, Mumbai-Maharashtra, 400001
Mumbai
MAHARASHTRA |
9821359301
ushakhemani@gmail.com |
| Dr H Bangaru |
K R Hospital |
First floor, Department of skin and STD, OPD no. 14, MMC & RI, Mysore-570001
Mysore
KARNATAKA |
8971832402
infokrhospital@gmail.com |
| Dr Pawan Kumar |
Kempegowda Institute Of Medical Sciences |
Second floor, B Block, Department of Skin and STD, KR road, Parvathipuram, Vishweshwarapura, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA |
9740557827
pawanpnc@gmail.com |
| Dr Keyur shah |
Medilink Hospital Research Center |
Basement medilink hospital, Near Shymal Char cross road, 132 ft. Ring road, Satellite, Ahmedabad- 380015
Ahmadabad
GUJARAT |
9879004822
drkeyurshah@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee Downtown Hospital |
Approved |
| Institutional Ethics committee, Grant Government Medical College |
Not Applicable |
| Institutional Ethics committee, Mysore Medical college and research institute and associated hospitals mysore |
Approved |
| KIMS Institutional Ethics Committee |
Not Applicable |
| Medilink Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Permethrin 5.0% w/w Cream |
Permethrin 30 gm tube applied topically once on dry and cool body surface once at time of recruitment. |
| Comparator Agent |
Permethrin 5.0% w/w Cream |
Permethrin tube applied topically once on dry and cool body surface once at time of recruitment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject is in good general health with normal appearing skin in non infected areas.
2.Subject is in good general health with normal appearing skin in non infected areas.
3.Clinical findings typical of scabies (burrows, erythematous papules, etc.) and microscopic confirmation of scabies mite, ova, or mite feces at classical sites.
4.Subject is able to provide written informed consent prior to study.
5.Willingness to comply with the study schedule and procedures. |
|
| ExclusionCriteria |
| Details |
1.Subjects with any condition which in opinion of the investigator makes the subject unsuitable for inclusion.
2.Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy (e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis).
3.Subjects used following within 4 weeks of baseline visit 1 immunomodulators 2 systemic medications that suppress the immune system 3 topical or oral parasiticides.
4.Subject used following within 2 weeks of baseline visit (1) topical steroids (2) topical or systemic antibiotics.
5.Subject has crusted scabies.
6.Subject with known history of irritation or sensitivity to parasiticides.
7.Known allergy or hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, plants in the Asteraceae/Compositae family (e.g. chrysanthemums, ragweed, marigolds, and daisies).
8.Subjects whose household members and close contacts refuse treatment.
9.Subjects whose sexual contacts do not agree to restrict prolonged skin to skin contact with non-household members during the study period.
10.Subjects with a household member less than 2 months of age.
11.Subject with signs of systemic infection or is receiving systemic therapy for an infectious disease.
12.Subjects with secondary bacterial infection based on subjective evidence.
13.Subjects with skin wounds, open injuries or other conditions of broken skin at the site of proposed application.
14.Subjects with history of severe cardiac, central nervous system, immunodeficiency, diabetes mellitus, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
15.Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
16.Participation in any other clinical trial during last 30 days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Proportion of responder during the 28 days will be compared between treatments. The responder will be defined as patients with no scabies remaining and at least 50% improvement in the VAS score for pruritus. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dermoscopy & confirmation of absence of mites, eggs/ova and/or mite feces by Microscopy.
Reported reduction or absence of pruritus (itching).
Clinical visual reduction or absence of scabietic lesions.
Percentage reduction in VAS scores for pruritus. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
05/07/2019 |
| Date of Study Completion (India) |
18/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Randomized, Double-Blind, Multicentric, Parallel group, comparative clinical study of Permethrin 5% cream of Morningside Healthcare Limited, UK (Test) vs Permethrin 5% cream of Medgenix Benelux NV (Belgium) (Reference) for the treatment of scabies. Subject with diagnosis of scabies who meet all the eligibility criteria, based on medical history and clinical examination will be screened in this study. The study will include 90 subjects of scabies. Screened subjects will be evaluated and the eligible subjects will be enrolled in the study. Subjects will be called for 7, 14 and 28 days. For all subjects, dermoscopic and microscopic evaluation for the presence of mite will be done on every visit. Primary endpoint assessment will be compared between treatments and there should be atleast 50 % improvement in VAS score for pruritus. Secondary assessment endpoint will be Dermoscopy & confirmation of absence of mites, eggs/ova and/or mite feces by Microscopy
|