Home » Trials » SLCTR/2019/035
Effectiveness of modified Whitfield’s ointment with oral griseofulvin in the treatment of dermatophytosis poorly responsive to standard treatment: A randomized, double-blind, within-patient-placebo-controlled clinical trial
-
SLCTR Registration Number
SLCTR/2019/035
Date of Registration
The date of last modification
Sep 15, 2020
Scientific Title of Trial
Effectiveness of modified Whitfield’s ointment with oral griseofulvin in the treatment of dermatophytosis poorly responsive to standard treatment: A randomized, double-blind, within-patient-placebo-controlled clinical trial
Public Title of Trial
Effectiveness of modified Whitfield’s ointment with oral griseofulvin in the treatment of skin fungal infection poorly responsive to standard treatment: A randomized, double-blind, within-patient-placebo-controlled clinical trial
Disease or Health Condition(s) Studied
Dermatophytosis
Scientific Acronym
None
Public Acronym
None
Brief title
Use of Griseofulvin and modified Whitfield's ointment in the treatment dermatophytosis poorly responding to standard therapy
Universal Trial Number
U1111-1235-8791
Any other number(s) assigned to the trial and issuing authority
2019/EC/47;FM UoP
What is the research question being addressed?
In patients with dermatophytosis poorly responsive to standard antifungal treatment (P), is the use of topical modified Whitfield’s ointment (I) effective in clinical clearance of the fungal lesions (O) compared to the placebo- topical emulsifying ointment (C) when given along with 500mg of oral griseofulvin as standard treatment?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Healthcare providers, Outcome assessors
Control
Placebo
Assignment
Single
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Study setting: The study will be conducted at the Department of Pharmacology, Faculty of Medicine, University of Peradeniya and the patients will be recruited from the out-patient dermatology clinic “Skin Centre”, Kandy. Patients with dermatophytosis poorly responsive to standard treatment as defined by poor clinical response to 2 or more systemic antifungals (terbinafine, fluconazole, itraconazole, griseofulvin) will be recruited. The lesions on the patients will be documented, photographed with a graduated scale in-situ and traced on to a tissue paper to measure the area of the lesion. Lesions will be randomized into two groups (bilateral-right and left, unilateral-proximal and distal, diffuse-superior and inferior). All patients will receive oral griseofulvin 500 mg daily dose to be taken along with a glass of milk/fatty meal. Half of the lesions will receive the modified Whitfield's ointment containing the active ingredient (6%/3% combination of Benzoic acid and Salicylic acid) and the other half of the lesions will receive only the emulsifying ointment without the active ingredient. Whitfield’s ointment and the emulsifying ointment will need to be applied twice daily on the respective lesions for a period of eight weeks or until patient achieves complete clearance of the lesions (prior to 8 weeks). However, the patient will need to take the oral griseofulvin for the total duration of 8 weeks to prevent relapses.The treatment will be handed over to the patient by a pharmacist. The physician, assessor and investigators will be blinded to the treatment. They will be assessed two weekly at the department of pharmacology. The modified Whitfield’s ointment will be prepared at the department of Pharmacology by a qualified pharmacist according to the standard protocol stated in the WHO’s Dermatological preparations for the Tropics/ointment or base according to the formula stated in the British electronic medical compendium which will be overseen by the principal investigator.
Inclusion criteria
Exclusion criteria
Contraindications for griseofulvin such as chronic liver disease, porphyria, SLE exacerbation
Patients who are on drugs that may lead to potential drug interactions with griseofulvin
Patients who have a history of adverse reactions to the ingredients of the modified Whitfield’s ointment
Pregnancy (Excluded by the last menstrual period, if unsure of the menstrual dates, treatment will be commenced after the next menstrual period)
Breast feeding
Patients with lesions involving the nails and scalp only.
Primary outcome(s)
|
1.
|
[ Every two weeks for a duration of 8 weeks from initiating the intervention. ] |
|
2.
|
[ Every two weeks for a duration of 8 weeks from initiating the intervention. ] |
|
3.
|
[ Every two weeks for a duration of 8 weeks from initiating the intervention. ] |
|
4.
|
[] |
|
5.
|
[] |
|
6.
|
[] |
|
7.
|
[] |
|
8.
|
[] |
|
9.
|
[] |
|
10.
|
[] |
|
11.
|
[] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
80
Countries of recruitment
Sri Lanka
Anticipated start date
2019-10-15
Anticipated end date
2020-09-15
Date of first enrollment
2020-01-20
Date of study completion
Recruitment status
Recruiting
Funding source
University Research Grant, University of Peradeniya
Regulatory approvals
None
Status
Approved
Date of Approval
2019-08-08
Approval number
2019/EC/47
Details of Ethics Review Committee
| Name: | Ethics Review Committee Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Ethics Review Committee Faculty of Medicine, University of Peradeniya Peradeniya |
| Telephone: | 0812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Sanjeewani Fonseka
Senior Lecturer
Department of Pharmacology,
Faculty of Medicine,
University of Peradeniya.
Peradeniya
0718074979
sanjeewani.fonseka@yahoo.com
Contact Person for Public Queries
Dr Sanjeewani Fonseka
Senior Lecturer
Department of Pharmacology,
Faculty of Medicine,
University of Peradeniya.
Peradeniya
0718074979
sanjeewani.fonseka@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual participant data collected during the trial, after de-identification, and individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices) will be shared. The study protocol and the statistical analysis plan will also be shared. Data will be shared within 3 months and end of 5 years following article publication. Data will be shared among investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose Data will be shared to achieve the aims in an approved proposal and for individual participant data meta-analysis. Data will be available by contacting sanjeeewani.fonseka@yahoo.com. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication at the University data warehouse but without investigator support other than deposited meta-data. Information regarding submitting proposals and accessing data may be found by e-mailing me at sanjeeewani.fonseka@yahoo.com. At the time of maintenance of placement of the data in a data repository, the link will be provided.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
