THE STATE OF ISRAEL 
MINISTRY OF HEALTH
TEL AVIV SOURASKY MEDICAL CEnter
Affiliated to the Tel-Aviv University
Municipality of Tel Aviv-Yaffo

PITRA-FIX METHOD FOR TOPICAL TREATMENT OF
ONYCHOMYCOSIS: A CLINICAL STUDY  
EVALUATION  
AVIKAM HAREL, M.D. FARCHI YOSSI, M.D
Pediatric Dermatology Unit, Dana Children`s Hospital,Tel Aviv, Israel

In this paper, we present a brief summery of an open uncontrolled clinical trial
Designed to evaluated the efficacy and safety of a new topical treatment for
Onychomycosis, the Pitra-Fix Method.

The study was preformed in the Pediatric Dermatology Unit in Dana Children`s
Hospital , Tel Aviv, from December-1998 to July- 1999.

SUBJECT AND METHODS

Fifty patients (aged 8-78) were enrolled in the study. In order to be included in the study, the patuents had to have mycologically proven onychomycosis and to have signed an informed patient consent form. Patients with immunosuppresset diseases, pregnant or lactatin women, and patients who had received systemic anti-fungal
Therapy during the year prior to the study were excluded from the study.

Patients were required to come for Pitra-Fix treatment once every two weeks for the
First two months (4 appointments), then once a month for the last four months (total
time = 6 months).

Efficacy was assessed mycologically at week 6, 12 and 24, clinically by two
Physicians who recorded the clinical status and documented with photographs at each
meeting. At the end of the study, the response was evaluated with the
following scale:
Complete cure: no residual clinical signs; negative results of mycological
examination.
Marked improvement: mild residual clinical signs; negative mycological
culture with possible microscopic findings.
Moderate improvement: clinical signs and symptoms decreased by >50%;
negative mycological culture with possible microscopic findings.
Failure: clinical improvement <50%: positive culture or microscopic findigs.

Patient satisfaction was measured by questionnaire filled out at the last meeting
Satisfaction was graded from 1 to 5 ranging from very satiafied to very dissatisfied.

PITRA-FIX METHOD OF TREATMENT

Topical treatment for onychomycosis based on trimming and buffing the affected part
Of the nail by a practitioner and applying an anti-fungal ointment composed of
Essential oils, urea and mixture of anti-fungal agents (boric acid, undecylenic acid,
Miconazal nitrate), and covered by gauze and adhesivetape.

For the firsttwo monts, the patientis instructed to apply the ointment once a day, to
Bandage the treated area, and to undergo the treatment by the practitioner once every
Two weeks. From this point until recovery, the practitioner trims the nails only if there is any clinical sign 0f affected nail and the patient applies the ointment daily
Without bandaging.

RESULTS
Of the fifty patients who anteredthe study, 13 (26%) droped out: 4 patients due to
Difficulties in following instructions; 6 patients difficulty keeping scheduled appointments; 2 patients disappeared; 1 patient due to allergic contact dermatitis.

Clinical: Of the fifty patients who completed the 24 weeks of the study:
5 (13.5%)- Failure
3 (8%) Moderate improvement
10 (27%) Marked improvement
19 (51%) Complete cure

Mycological: Of the 37 patients who completed the study, 6 patients had Candida onychomycosis and 31 patients had dermatophytes T. Rubrum T. Mentagrophytes, E. Fluconium.)
28 (76%) Mycological cure (negative culture, no microscopic findings)
4 (11%) Mycological failure (positive culture, and microscopic findings)
5 (13%) Mycological improvement (negative culture with some microscopic findings)

Satisfaction: 33 of the patients were very satisfied with the treatment. No
Dissatisfaction was expressed even among those who failed to respond.

SIDE EFFECTS

No side effects or unpleasant reaction to the treatment were observed except for
4 cases of peeling of the skin close to the nail and 1 patient with allergic
Contact dermatitis who stoppedthe treatment.

CONCLUSIONS

No difference was observed between the clinical and mycological response to the treatment with respect to the type of fungus, however one has to take into account the uneven distribution of fungus types among the patients.

Most of the patients (34 out of 37) were treated for toenail onychomycosis. All three patients with fingernail onychomycosis had shown complete cure however due to the limited size of the patient sample a decisive conclusion is premature.

We have strong reason to believe that most of the patients who showed " marked improvement" would have shown complete resolusion of the disease if the treatment had been wxtended for two or three more months.

From the high rate (26%) of drop out from the study, we learned that this treatment, which is time-consuming and requires high compliance of the patient, may not be suitable for all patients,and requires careful patient selection on the part of the clinician.

The high rate of mycological and clinical success of Pitra-Fix Method makes this topical treatment an effective safe alternative for those patients who are unable to tolerate systemic treatment due to illness, age, drug interaction, pregnancy or lactation and for those who refuse systemic treatment.