Efficacy of a new aluminium salt thermophobic foam in the treatment of axillary and palmar primary hyperhidrosis: a pilot exploratory trial.

BACKGROUND: Primary or idiopathic hyperhidrosis (PH) is a disorder of excessive eccrine sweating glands that mainly affects the axillae and the palms. The treatment options for PH involve a range of topical or systemic medication and/or surgical invasive techniques. The common topical treatments are aluminium salts which act by blocking the duct of the eccrine gland or by atrophying the secretory cells. Recently, a new low-residue thermophobic foam formulation (VersaFoam, Mipharm Spa, Milan, Italy), containing 20% of an aluminium salt (sesquichlorhydrate), has been developed. The foam is easy to apply especially in hairy body sites. OBJECTIVE: to evaluate the efficacy and the tolerability of the new aluminium salt foam in the treatment of axillary and palmar PH. PATIENTS AND METHODS: Twenty patients were enrolled in a single-centre, open-label follow-up study. The Minor test score (range 0-3) and the Dermatology Life Quality Index (DLQI), were used to evaluate the amount of sweating and the impact on quality of life. The foam was applied to dry, clean skin, every night during the first week of treatment, and three times a week during the second week of treatment. Evaluation of the results was performed at baseline and at 7 and 15 days after treatment. Patients were monitored throughout the study for adverse events. RESULTS: All of the 20 enrolled patients completed the study. The foam resulted in a significant reduction of the Minor score in comparison with baseline values in both the axillary (p = 0.0002) and palm regions (p = 0.0047). By the end of treatment (day 15) the foam had reduced the amount of sweating in the axillae and palm regions by 50% (Minor score: 4.1 vs. 8.1) and 53% (Minor score: 4.0 vs. 8.5), respectively. Use of the foam showed a positive impact in the DLQI for patients with axillary but not palm hyperhidrosis. No side effects were reported during the study duration by the patients. CONCLUSION: The new foam has been shown to be an effective topical treatment in reducing sweating in patients with axillary and palm PH. This formulation is well tolerated in the short term. Further studies are warranted to evaluate the efficacy and safety in the medium and long term.