A randomised control experiment comparing the efficacy of combination antifungal cream containing ketoconazole, zinc oxide, transcutol and lactic acid with ketoconazole cream alone for treating fungal infections of skin

Effectiveness of antifungal cream containing two percent ketoconazole, zinc oxide, transcutol and lactic acid vs two percent ketoconazole in the management of treatment naive cutaneous superficial fungal infections A randomized open label control trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095502

Enrollment

150

Registered

2025-09-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: B368- Other specified superficial mycoses

Interventions

Intervention1: Antifungal cream containing 2% ketoconazole, zinc oxide, transcutol and lactic acid: Another group will be initiated on topical antifungal cream containing 2% ketoconazole, zinc oxide,

Eligibility

Inclusion criteria

Inclusion criteria: Consenting participants of age group 18- 65 years with clinically proven treatment naive cutaneous superficial dermatophytosis and tinea versicolor infections with symptoms for at least one week

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women 2. Participants with deep fungal infections or infections affecting the scalp, nails, or mucosal areas 3. Immunocompromised individuals 4. Known allergies or sensitivity to any ingredients in the study formulation 5. Unwilling to comply with study procedures

Design outcomes

Primary

Measure	Time frame
Overall clinical improvement, DSS score and reduction in pruritus, scaling and color in cutaneous superficial fungal infectionsTimepoint: 0, 3 and 6 weeks	—

Secondary

Measure	Time frame
Adverse effects, recurrence rates and patient satisfaction will be assessedTimepoint: 0, 3 and 6 weeks	—

Countries

India

Contacts

Public ContactMridula T

Saveetha medical college and hospital, Saveetha institute of medical and technical sciences

b.abyramy@gmail.com7598566974

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026