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

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SLCTR Registration Number

SLCTR/2019/035


Date of Registration

07 Oct 2019

The date of last modification

Oct 11, 2019



Application Summary


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


Trial Details


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

  1. Both male and female
  2. Age more than 18 years
  3. Clinically confirmed dermatophytosis, poorly responsive to standard antifungal therapy (dermatophytosis for a duration of 3 months or more which has been treated with 2 or more systemic antifungals).
  4. Presence of two or more skin lesions of dermatophytosis

Exclusion criteria

  1. Contraindications for griseofulvin such as chronic liver disease, porphyria, SLE exacerbation

  2. Patients who are on drugs that may lead to potential drug interactions with griseofulvin

  3. Patients who have a history of adverse reactions to the ingredients of the modified Whitfield’s ointment

  4. Pregnancy (Excluded by the last menstrual period, if unsure of the menstrual dates, treatment will be commenced after the next menstrual period)

  5. Breast feeding

  6. Patients with lesions involving the nails and scalp only.



Primary outcome(s)

1.
  1. Clinical clearance of the skin lesions by percentage reduction in the size of the lesions by tracing on to a tissue paper/improvement of the symptoms
[

Every two weeks for a duration of 8 weeks from initiating the intervention.

]
2.
  1. Microbiological clearance of the fungal infection as demonstrated by direct microscopy (20% KOH + Parker's Indian Ink) by obtaining skin scrapings from the lesions.
[

Every two weeks for a duration of 8 weeks from initiating the intervention.

]
3.
  1. Assessment of the patient’s perception of clinical symptoms: pruritus, size, scaling, irritation based on the VAS (0-10).
[

Every two weeks for a duration of 8 weeks from initiating the intervention.

]
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Secondary outcome(s)

1.

None

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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


Date of study completion


Recruitment status

Pending


Funding source

University Research Grant, University of Peradeniya


Regulatory approvals

None



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

University of Peradeniya, Peradeniya.





Secondary study sponsor (If any)

None





Trial Completion details


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