Preclinical and Clinical studies to evaluate the safety and efficacy of Unani Topical Formulation for Dermatophytosis.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and effficacy of the Unani Formulated Ointment in Dermatophytosis.
Study Overview
Brief Summary
Study will be conducted on 30 patients of either sex supported by inclusion, exclusion criteria with informed consent.
Prior to the conduction of the study, safety evaluation of the formulation was evaluated. The following parameters also being noted:
1- Primary Irritation study: 24-, 48-hour 72 or 96-hour single-application patch tests to evaluate the primary irritation (acute skin irritation) potential of test drug, if any.
2-Cumulative Patch Irritation study: It is conducted to evaluate the test drug to assess if a chemical ingredient present in the test drug have the potential to cause contact irritation or contact allergy in the skin. 14-day or 21-day patch test is used to investigate the potential irritation from chronic exposure.
3-Forearm Controlled application test (FCAT): Helps to quickly evaluate the relative skin benefits of various skin formulations.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 16.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •fungal hyphae in a 10% potassium hydroxide (KOH) Patients aged 14year old to 65 years old.
Exclusion Criteria
- •Immunocompromised Pregnant ladies Lactating women Patients with secondarily infected or eczematized lesions Medical comorbidities Uncontrolled Diabetes.
Outcomes
Primary Outcomes
To evaluate the safety and effficacy of the Unani Formulated Ointment in Dermatophytosis.
Time Frame: To evaluate the safety and effficacy of the Unani Formulated Ointment in Dermatophytosis.
Secondary Outcomes
- Correlate the efficacy with the MIC.(20/04/25)
Investigators
PROF ZAMIR AHMAD
AJMAL KHAN TIBBIYA COLLEGE