A randomized, open label, prospective investigator initiated interventional study to understand the effects of addition of broad-spectrum antimicrobial skin healing cream (Silversol plus coconut oil plus vitamin E plus Hyaluronic acid) as an adjuvant to an antifungal agent in the management of superficial skin fungal infections.

A randomized, open label, prospective investigator initiated

interventional study to understand the effects of addition of broad-

spectrum antimicrobial skin healing cream (Silversol plus coconut

oil plus vitamin E plus Hyaluronic acid) as an adjuvant to an

antifungal agent in the management of superficial skin fungal

infections.Physicians are finding it difficult to manage fungal infections. They are trying all available antifungals in their arsenal with all possible

combinations. Sometimes an oral antifungal is tried with two

different topicals while other times two orals are tried with one

topical. Despite these efforts controlling fungal epidemic seems

challenging. Although new antifungals are the need of an hour

bringing new molecules to market is daunting and time-consuming

affair. Given this scenario, optimizing the use of available antifungal

agents becomes very important.Broad-spectrum antimicrobial skin healing cream has metallic silver

nanoparticles in the form of Silversol which can offer antimicrobial

action and thereby help in optimizing the use of available antifungal

agents. Apart from that it has coconut oil and hyaluronic acid which

can help maintain skin moisturization, and Vitamin E which can

fight oxidative stress associated with fungal infection.

Thus, this study aims to find out whether adding broad-spectrum

antimicrobial skin healing cream to standard antifungal therapy can

lead to better outcomes in the real world.To understand the clinical and mycological implications of adding a

broad-spectrum antimicrobial skin healing cream to antifungal

therapy for the management of superficial skin fungal infections.For clinical cure the following signs and symptoms will be assessed:

erythema, pruritus, and scaling. Each parameter will be measured on

4-point scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe).

The investigator will assess [Physician Global Assessment (PGA)]

these parameters for all 5 visits.

For mycological cure, KOH testing will be done at baseline and at the

end of the treatment (EOT) i.e. at the end of 10 weeks.

Clinical and mycological cure rates will be compared in two arms.

Secondary outcomes:

Secondary efficacy will be determined by presence of recurrence {re-

occurrence of a lesion within few weeks (<6 weeks) after completion of

treatment} or relapse {Occurrence of lesion after a longer infection

free period (6 to 8 weeks) in a patient who has been cured clinically}

post completion of treatment by observing clinical signs and

symptoms for fungal infection.

Rate of recurrence or relapse in both groups will be compared.

For tolerability assessment, adverse effect/s will be monitored and

documented (if any), and will be compared in both groups at the EOT.A total of 100 patients (50 per arm) with superficial fungal infections

(Tinea infections) will be recruited together for both arms.This will be an investigator initiated interventional, controlled study.