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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2019/035

Enrollment

Registered

2019-10-07

Start date

2019-10-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatophytosis

Interventions

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 “

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.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.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.] [ ] [ ] [ ] [ ] [ ] [] [ ] [ ]	—

Measure

Time frame

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.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.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.] [ ] [ ] [ ] [ ] [ ] [] [ ] [ ]

—

Secondary

Measure	Time frame
None []	—

Countries

Sri Lanka

Contacts

Public ContactDr Sanjeewani Fonseka

Senior Lecturer

sanjeewani.fonseka@yahoo.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026