| CTRI Number |
CTRI/2012/03/002522 [Registered on: 27/03/2012] Trial Registered Retrospectively |
| Last Modified On: |
27/03/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of drugs Calmagen cream and lotion in patients for topical treatment of Tinea (ringworm infection). |
|
Scientific Title of Study
|
A single centre, double blind, placebo controlled, randomized, confirmatory efficacy study of biovite®s calmagenTM dermaceutical cream & lotion for the topical treatment of tinea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MA-CT-09-012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Parekh |
| Designation |
Consultant Dermatologist |
| Affiliation |
Apollo Clinic |
| Address |
The Apollo Clinic
No.65, Madhavaraya Mudliar Road
Bangalore
KARNATAKA
560005
India |
| Phone |
080-25808081 |
| Fax |
|
| Email |
drmanojparekh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girisha R |
| Designation |
Senior Medical Writer |
| Affiliation |
Manipal Acunova |
| Address |
Manipal Acunova Limited
EPIP, Whitefield,
Bangalore
KARNATAKA
560066
India |
| Phone |
08066915775 |
| Fax |
08066915719 |
| Email |
girisha.r@ecronacunova.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Rakesh Naranbhai Dadhania |
| Designation |
Head of clinical operations |
| Affiliation |
Manipal Acunova |
| Address |
Manipal Acunova Limited
EPIP, Whitefield,
Bangalore
KARNATAKA
560066
India |
| Phone |
08066915757 |
| Fax |
08066915719 |
| Email |
rakesh.dadhania@ecronacunova.com |
|
|
Source of Monetary or Material Support
|
| Biovite Australia Pty Ltd |
|
|
Primary Sponsor
|
| Name |
Biovite Australia Pty Ltd |
| Address |
(Biovite)Unit 1, Enterprise Plaza45 Township DriveWest Burleigh, Queensland 4219 AUSTRALIA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Parekh |
The Apollo Clinic |
#65, Madhavaraya Mudliar Road,-560005
Bangalore
KARNATAKA |
080-25808081
drmanojparekh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Superficial Tinea Infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A matching placebo cream & lotion, |
Twice daily Topical application for 3 months; once daily for 3 months (during observation phase) |
| Intervention |
Biovites® CalmagenTM Dermaceutical cream & lotion, |
Twice daily, Topical application for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
To be eligible for entry in this study, patient must:
1. Be a male or female ≥ 18 years of age
2. Be diagnosed by the Principal Investigator or designee as suffering from Tinea of combined severity (itching, erythema and scaling) score of 8 or more as in appendix 3 or severe grade of onychomycosis as in appendix 4 of protocol
3. Subjects with positive KOH and positive fungal culture test along with identification of the dermatophyte and presence of live spores.
4. Understand and conform to the procedures involved in and agree to participate in the study by giving informed, written consent.
5. Be able to give consent for taking photographs of the affected region before, during and after the study period.
|
|
| ExclusionCriteria |
| Details |
To be eligible for entry in this study, patient must not:
1. Have used any oral or topical Tinea treatments, within one week prior to the screening assessment.
2. Have ingested any drug in the week prior to the start of treatment or during the treatment period, which, in the opinion of the Principal Investigator, could compromise the study (Note: Oral, injectable or implant contraceptive for female volunteers is acceptable).
3. Have history of allergy or intolerance to any drug, which in the opinion of the principal investigator poses a risk to the patient
4. Be pregnant or breast-feeding females.
5. Have received an investigational drug or participated in a clinical trial within the last 30 days
6. Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Principal Investigator, may be jeopardized by participation in this study or by the complications of this therapy
7. Hypersensitivity to Biovite® dermaceutical formulation (cream & lotion)
8. Patient with a positive test for hepatitis B, C, and who is positive or reactive for antibodies to HIV 1 and 2.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mycological cure assessed by negative KOH preparation, fungal culture, and reduction in live spore counts at the end of study |
End of study (4 weeks for Tinea & 12 weeks for Onychomycosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the extent and the severity of onychomycosis since baseline and at the end of the study. |
End of study (12 weeks for Onychomycosis) |
| Reduction in the size and the severity of tinea lesions since baseline and at the end of study |
End of study (4 weeks for Tinea) |
| Improvement in lesions assessed by photographic record at baseline and at end of study |
End of study (4 weeks for Tinea and 12 weeks for Onychomycosis) |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/03/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
|
|
Brief Summary
|
This is a randomized, double blind, placebo controlled, parallel-group, single center, study designed to confirm the efficacy of Biovite®’s CalmagenTM Dermaceutical cream & lotion for topical application to the affected areas of skin in patients of either sex with severe to very severe presentations of Tinea. The study is divided in three main phases: (a) 1 to 15- days Screening Phase and Randomization (b) Variable Treatment Phase (2 to 12 weeks) (c) Observation phase (12 weeks) The study population will consist of ambulatory human adult male and female patients with clinically proven severe presentations of Tinea who will be randomized to receive either: Treatment A: Biovite®‟s CalmagenTM Dermaceutical cream or lotion for topical application to the affected areas of skin or nails. Treatment B: Placebo cream or lotion for topical application to the affected areas of skin or nails.
The constituents of Biovites Calmagen dermaceutical cream are: very early form of plant life (“Bioactiveâ€) named AMYCOT |