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

Phase 3

Recruiting

Conditions: Dermatophytosis

Registration Number: SLCTR/2019/035

Lead Sponsor: niversity of Peradeniya, Peradeniya.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br> [Every two weeks for a duration of 8 weeks from initiating the intervention.]<br> 2.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.]<br>3.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.]<br> [ ]<br> [ ]<br> [ ]<br> [ ]<br> [ ]<br> []<br> [ <br>]<br> [ ]<br>

Secondary Outcome Measures