Mycoderm Spray

Adjuvant treatment for superficial fungal infections of the skin: Tinea Versicolor

Fungi comprise a common cause of dermal infections all around the world. An individual’s risk of ever suffering such infections in his/her lifetime is 10-20 percent; among them Tinea Versicolor is the most prevalent infection. Tinea Versicolor is a benign, chronic, and often asymptomatic superficial cutaneous fungal infection, which is characterized by spots of various sizes and colors along with fine or bran-like scales. The macules are usually scattered over the chest, arms, abdomen and back. Tinea versicolor is caused by the lipophilic yeast, Malassezia furfur, which becomes virulent under such circumstances as use of corticosteroids, chronic infections, excessive perspiration and pregnancy. This infection is more prevalent in hot and humid regions (like the north and south of the country, or shores of Urmia lake) and in youngsters. The yeast is contracted by direct exposure to the infectious scales, for instance while swimming in public pools or at sea, or using the underwear or towels of an infected individual; those infected do not usually complain except for mild itching and alteration of skin color.

Several oral and topical medications, such as those of imidazole group and amino acids, are used to treat this infection; some involving failure of treatment, extensive adverse effects and recurrence. Therefore, extensive efforts have been made to find natural substances that can affect this disease. Among the plants that have been surveyed is artemisiam, which is regarded as antiseptic, analgesic and antitussive in traditional medicine. Several studies have also reported the antibacterial and antifungal properties of essential oil of Artemisia species.

In laboratory, Artemisia essential oil manifests antifungal properties. For instance, its Minimum Inhibitory Concentration (MIC) against Tinea versicolor is reported to be 1:1280. Based on the results of one report, after 14 weeks of treatment with Artemisia lotion, the onychomycosis of a patient, who was unable to take griseofulvin due to hepatic problems, was cured.

In a test run on animals (dog and cat) suffering from dermatophytosis, full recovery was achieved in 77.3% of the cats and 71.4% of the dogs under treatment with Artemisia essential oil; the numbers in the case of those under treatment with clotrimazole were 70.8% and 66.7%, respectively. In this survey, no significant difference was observed between Artemisia essential oil and clotrimazole, in terms of clinical recovery and mycological results.

In a double-blind clinical trial, 68 patients (34 men and 34 women) of 6-61 years of age with Tinea versicolor, who had received no medication previously, were visited by dermatologists and the diagnosis was confirmed through direct microscopic study. The patients were randomly sorted into two groups of Mycoderm Lotion (37 individuals) or clotrimazole lotion (31 individuals) and were administered the lotions locally twice a day for two weeks. Furthermore, 34 patients with Tinea Versicolor were administered placebo as positive control. The patients were followed up for 2 weeks after completion of the treatment to monitor the recurrence of the disease. Clinical and laboratory findings were registered 2 weeks after the commencement of treatment and in the 2 succeeding weeks. The data were analyzed using chi-squared, Wilcoxon and independent t-test. According to the results of this survey, the most prevalent clinical finding was pink/brown macules. Clinical findings indicated recovery after 2 weeks of treatment, but many patients manifested signs of recurrence after 2 weeks of follow-up. 2 weeks after the commencement of the treatment, the rate of recovery in the clotrimazole group was 71% and 91.9% in the Mycoderm group, while 4 weeks after the treatment, the rate of recovery in the clotrimazole group was 67.7% and 100% in the Mycoderm group (p<0.001) and the efficacy of the two medications was statistically significant (p<0.007). At the end of the study, 51.6% of the patients in the clotrimazole group and 70.3% of the Mycoderm group were cured. Out of the 34 patients in the positive control group, patients who received placebo, only 3 showed relative clinical recovery. The researchers came to the conclusion that, due to the obvious inhibition of Malassezia furfur by Artemisia essential oil, Mycoderm can be effective as an adjuvant treatment of Tinea versicolor as a topical medication applied twice daily

Depending on the area of infection, two times a day, maximum 4 puffs each time. The course of treatment is 2-4 weeks, as suggested by the physician.    

Dosage form

Spray

 

Packaging

30 ml syrup bottle in cardboard box

Patient information leaflet inside

Ingredients

  • Essential oil of artemisia (Artemisia sieberi)

Active Ingredients

  • alpha-thujone

Contraindications

  • Pregnancy, lactation, children
  • Patients suffering seizures

 

Adverse Effects

With the recommended dosage and appropriate administration, no adverse reaction has been reported. However, in sensitive individuals, dermal allergic reactions like burning, itching and rash may occur.

Drug Interaction

No reported drug interaction.

 

Administration during Pregnancy and Lactation

Not allowed.

 

Further Notes

  • Keep Mycoderm spray, like all other medication, away from sight and reach of children.
  • Avoid using the spray on open wounds and mucosal membranes, including the eyes.
  • Before using Mycoderm, also for an administration period of more than 15 days, consult a physician or a pharmacist.
  • Tightly close the container after application and keep the medicine away from light and in 15-30°C.
  • Keep this leaflet; you may need to read it again.

Based on presence of at least 15 mg alpha-thujone per ml of the product.