| CTRI Number |
CTRI/2018/04/012971 [Registered on: 03/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of sertaconazole, eberconazole and miconazole creams in treatment of ringworm infection. |
|
Scientific Title of Study
|
Randomized controlled trial of topical sertaconazole and eberconazole in comparison to topical miconazole in localized dermatophyte infection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPGME&R / Pharma / 2015 / CT-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prajesh Kiran Bhunya |
| Designation |
Resident |
| Affiliation |
IPGMER Kolkata |
| Address |
Department of Pharmacology IPGMER 244 AJC Bose Road Kolkata
Kolkata WEST BENGAL 700020 India |
| Phone |
7431806060 |
| Fax |
|
| Email |
pkbsmch014@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prajesh Kiran Bhunya |
| Designation |
Resident |
| Affiliation |
IPGMER Kolkata |
| Address |
Department of Pharmacology IPGMER 244 AJC Bose Road Kolkata
WEST BENGAL 700020 India |
| Phone |
7431806060 |
| Fax |
|
| Email |
pkbsmch014@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Avijit Hazra |
| Designation |
Professor |
| Affiliation |
IPGMER Kolkata |
| Address |
Department of Pharmacology IPGMER 244 AJC Bose Road Kolkata
Kolkata WEST BENGAL 700020 India |
| Phone |
9831188172 |
| Fax |
|
| Email |
blowfans@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology IPGMER Kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology |
| Address |
IPGMER
244 AJC Bose Road, Kolkata 700020. |
| Type of Sponsor |
Government medical college |
|
|
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 Prajesh Kiran Bhunya |
IPGMER |
OPD, Department of Dermatology
244 AJC Bose Road Kolkata 700020 Kolkata WEST BENGAL |
7431806060
pkbsmch014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tinea (dermatophytosis) excluding hair and nails, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eberconazole |
Topical eberconazole nitrate 1% (w/w in cream base) applied twice daily for 4 weeks. |
| Comparator Agent |
Miconazole |
Topical miconazole nitrate 2% ( w/w in cream base) applied twice daily for 4 weeks. |
| Intervention |
Sertaconazole |
Topical sertaconazole nitrate 2% ( w/w in cream base) applied twice daily for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from dermatophyte infection in the form of localized tinea lesions such as tinea corporis and tinea cruris.
2. Willing to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Female patients who are pregnant or breast feeding.
2. Patients with disseminated tinea infection.
Patients with uncontrolled diabetes mellitus or severely immunocompromising disorders like HIV/AIDS.
3. Patients with serious disease of vital organs like heart, lungs, liver, kidney or bone marrow.
4. Patients suffering from alcoholism, other substance abuse disorders or active psychiatric disorders.
5. Patients with history of hypersensitivity to systemic or topical formulations of azole antifungals including miconazole, sertaconazole or eberconazole.
6. Participation in another clinical trial within last 30 days.
7. Any other condition, which in the opinion of the principal investigator, will prevent the subject from complying with visit schedules and instructions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical cure at 4 weeks – implying resolution of the lesion and associated symptoms. |
Baseline 2 weeks 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical cure at 2 weeks. |
2 weeks |
| Changes in Total Symptom Score (TSS) based on erythema, scaling, and pruritus scores. |
Baseline 2 weeks 4 weeks |
| Overall response at 4 weeks based on 6 point global response scale. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="210" Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "206"
Final Enrollment numbers achieved (India)="206" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/12/2015 |
| Date of Study Completion (India) |
29/06/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Skin
is a protective barrier also has cosmetic value. Dermatophyte infection is
commonest superficial fungal infection in the world which affect skin, hair
nail. It is more prevalent in tropical countries like India. Dermatophyte
infection can cause significant morbidity. Working days may be lost and social
life may be affected. Several environmental, social and immunological factors
contributes to the disease. Disease like diabetes malignancy HIV/AIDS which decreases immunity and
immunosuppressive drugs, steroid use prolongs disease. For the treatment of
superficial fungal diseases topical antifungal agents are used. Imidiazole
group antifungal miconazole is a common drugs used in this purpose. Newer
imidiazole antifungals like sertaconazole and eberconazole claims to have
better efficacy than miconazole as they have additional anti-inflammatory
property. The imidiazole group of antifungal drugs attains significant amount
of concentration in superficial layers of skin. Drug level in deeper layer and
systemic absorption is negligible. They penetrate horny layer of skin and
remains there for long time, so their use in superficial fungal infection is
preffered.
The
objective of the study was to carry out a head-to-head comparison of the newer
imidazoles, topical sertaconazole and topical eberconazole, with the
established topical antifungal miconazole in the management of cutaneous
dermatophyte infection with respect to both effectiveness and safety.
Over a
recruitment period of 12 months 206 patients who gave consent were randomized to
three study arms. First follow up visit was at 2 weeks and end of study visit
was at 4 weeks. Overall, 69 patients on miconazole, 62 on sertaconazole and 68 on
eberconazole completed the study.
Baseline
characteristics of all three groups were comparable. We looked for decrease in
erythema, pruritus, scaling and total symptom score. These parameters decreased
significantly from base line to 2nd week follow-up and to study end in each of
the three study groups, with no significant intergroup differences at any time
point. Complete clinical cure (that is resolution of lesion with all associated
symptoms) in miconazole, sertaconazole, eberconazole group was 46.38%, 46.77%
and 58.82% respectively. This difference was not significant statistically. However,
clinical cure rate at 2 weeks was 3.23% and 16.18% in sertaconazole and
eberconazole group respectively (p = 0.018) without any such case in the
miconazole. Compliance, assessed with the help of a medication adherence record
sheet, was good to excellent in most study subjects. No clinically significant
adverse drug reactions were noted in any study arm.
Therefore,
in conclusion, despite an early trend favoring eberconazole, clinical cure at 4
weeks was comparable with the older drug miconazole. Clinical cure was not
achieved in approximately 50% of the subjects at 4 weeks. Tolerability of all
three preparations was excellent. |