The pharmacological treatment and management of hyperhidrosis.

INTRODUCTION: Idiopathic hyperhidrosis is a dysfunctional disorder involving eccrine sweat glands, and its impact on patients' daily quality of life is well known. Unlike some years ago, when only poor effective and safe therapeutic alternatives were available, nowadays, several emerging pharmacological active substances have gained significant space as treatment options. AREAS COVERED: The authors report on, in this narrative review, the emerging data from the literature focusing on the pharmacological treatments to draw up a drug treatment flow chart for patients with idiopathic hyperhidrosis, taking into consideration specific differences among axillary, palmoplantar, and craniofacial hyperhidrosis. EXPERT OPINION: Idiopathic hyperhidrosis, regardless of the site of involvement, remains a functional disorder that places a significant burden on patients. After balancing efficacy against adverse events, systemic therapy, although off-label for all forms of hyperhidrosis, can be an added therapeutic option for patients with insufficient response to topical treatment. Until the pathophysiological mechanisms underlying hyperhidrosis are clear and the etiological therapeutic approach becomes realistic, the greatest challenge in the therapeutic management of hyperhidrotic patients seems to be the search for the most convenient combination between different therapeutic modalities (topical and systemic agents, and botulinum toxins) to achieve long-term control of the disease symptoms.

Effects of in vivo application of an overnight patch containing Allium cepa, allantoin, and pentaglycan on hypertrophic scars and keloids: Clinical, videocapillaroscopic, and ultrasonographic study.

Several therapeutic approaches have been described for their treatment of hypertrophic scars and keloids, but to date, the optimal treatment has not been established yet. Our in vivo study was conducted to evaluate the effect of a medical device consisting in an adhesive patch containing onion extract (Allium cepa) 10%, allantoin 1%, and pentaglycan 4% (Kaloidon patch) on hypertrophic scars and keloids. Thirty-nine patients with hypertrophic scars and seven patients with keloids were asked to apply an adhesive patch containing Allium cepa, allantoin, and pentaglycan once/day for at least 8 h consecutively, for 24 weeks. Patients were reevaluated 6 weeks (T6), 12 weeks (T12), and 24 weeks (T24) after starting the treatment through POSAS scale v 2.0, ultrasonographic, and videocapillaroscopic assessment. The investigated medical device was able to induce a significant improvement of POSAS starting from T12, with a positive amelioration trend until T24. However the patient-assessed POSAS sub-items showed improvement already after 6 weeks, whereas a significant improvement of the observer-assessed POSAS sub-items was observed only after 12 weeks (P < .001). Ultrasonography and intravital videocapillaroscopy confirmed a significant improvement of skin scars thickness (P < .001) and vascularization (P < .001) after 12 weeks of medical device application at least, with increasing improvement until T24. Applying an adhesive patch containing Allium cepa, allantoin, and pentaglycan once a day for at least 8 consecutive hours seems to be able to improve the clinical and morphological characteristics of the scars of the skin in 24 weeks.

The new therapeutic choice of tranexamic acid solution in treatment of erythematotelangiectatic rosacea.

BACKGROUND: Erythematotelangiectatic rosasea is a common,chronic, relapsing disease characterized mainly by vascular components, for which many therapies may exist but with limited efficacy. OBJECTIVES: We decided to test the efficacy of tranexamic acid when applied topically on the affected areas.,Tranexamic acid is an antifibrinolytic,thus we considered it could be effective at this type of rosacea. METHODS: This is an unblinded study. We included 20 patients, having erythematotelangiectatic rosacea. All patients were women between 27 and 65 years-old. We divided the patients in two groups,the first group was treated only with tranexamic acid solution (Transamin inj/sol 500 mg/5 mL) infused wet dressing for 20 minutes, and the second group was treated with microneedling simultaneously with tranexamic acid solution topical application followed by tranexamic acid solution infused dressing therapy,every 15 days for four sessions. RESULTS: The improvement assecion was outlined according to the Investigator Global Assessment of Rosacea Severity Score (IGA-RSS) and the use of clinical photos and dermoscopy. All patients were improved in the end of the therapy. There was statistically significant improvement, 2 units IGA-RSS in the first group, whereas 3 units IGA-RSS in the second group. The improvement lasted more than four months. The tolerability of the use of tranexamic acid was also asessed. CONCLUSIONS: According to our results a new really promising simple, safe and cheap treatment option targeting mainly to the vascular net and the erythema of rosacea is proposed.

An extension of a multicenter, randomized, split-face clinical trial evaluating the efficacy and safety of chromophore gel-assisted blue light phototherapy for the treatment of acne.

A variety of laser/light-based devices have been reported to be effective for the treatment of acne, yet no long-term data on efficacy and safety have been published. A first 12-week clinical trial ("Main trial") recently demonstrated that the KLOX BioPhotonic System, an LED blue light device using photo-converter chromophores, can significantly improve moderate and severe facial acne vulgaris with an excellent safety profile. This Extension trial followed the Main trial, using the same BioPhotonic System, with the same dose and instructions for use, on patients having already completed treatment in the Main trial. Main objectives of this open-label long-term extension 12-week study were to evaluate the efficacy of the KLOX BioPhotonic System on the untreated hemiface during the Main trial, as well as the duration of response on the hemiface treated during the first 12-week Main trial. Despite their young age (mean age: 21.6 years) and their 12-week participation in the Main trial, 49 (54.4%) of the total number of patients who participated in the Main trial enrolled in this additional 12-week Extension trial. Baseline grading of acne was performed with the Investigator's Global Assessment (IGA) scale. For each patient, the hemiface randomly selected as a control during the Main trial received 6 weeks of treatment (twice weekly) and was then followed up for an additional 6 weeks. The first hemiface treated in the Main trial was consequently observed throughout the Extension trial, allowing for a further 12-week assessment of outcomes (total 24 weeks). In light of an additional 12 weeks of treatment on the contralateral face, the patient compliance rate was excellent, with 91.9% of the total number of patients receiving at least 80% of the treatments. Patients with a baseline IGA grade of 2 (mild) on the treated hemiface demonstrated a success rate of 58.3 and 66.7% at weeks 6 and 12, respectively. At these same time points, subjects with a baseline IGA grade of 3 (moderate) demonstrated a success rate of 81.8 and 90.0%. Patients with a baseline IGA grade of 4 (severe) demonstrated a success rate of 100% at both week 6 and week 12. When evaluating the originally treated hemifaces from the Main trial, the rate of return to baseline at 24 weeks was calculated to be 15.5%. This latter outcome confirmed the long duration of effect following treatment. The patient safety profile was also excellent, with very few related adverse events. The BioPhotonic System, which is comprised of LED blue light phototherapy and photo-converter chromophores, provides long-term efficacy and safety in the treatment of acne vulgaris, with a rate of compliance above what is generally observed in a young population of patients suffering from acne vulgaris, especially in light of sequential enrollment in a study treating one hemiface.

A multicenter, randomized, split-face clinical trial evaluating the efficacy and safety of chromophore gel-assisted blue light phototherapy for the treatment of acne.

BACKGROUND: Although a variety of laser/light-based devices have been reported to be effective for the treatment of acne, long-term data on efficacy and safety in the management of moderate and severe inflammatory acne is lacking. The objective of this 12-week clinical trial was to evaluate the efficacy and safety of the KLOX BioPhotonic System, a LED blue light device using specific photo-converter chromophores, in the treatment of moderate to severe acne vulgaris. METHODS: One patient hemiface was randomly selected to receive 6 weeks of treatment (twice weekly) with the LED light and the photo-converter chromophores whereas the contralateral hemiface was not treated with the BioPhotonic System. All patients were provided with a skin cleanser and a non-comedogenic cream with ultraviolet protection to be used on the entire face during the treatment period. Following completion of the 6-week treatment period, the patient was followed for an additional 6 weeks. Efficacy was assessed through changes in acne severity using the Investigator's Global Assessment (IGA) scale and inflammatory acne lesion counts, both evaluated against baseline at weeks 6 and 12. Safety was assessed through physical exam, vital signs, laboratory evaluations, and physician and patient reporting of adverse events. RESULTS: A reduction of at least two grades in IGA scale severity was demonstrated in 51.7% of patients at week 12. Furthermore, at week 12, subjects with a baseline IGA grade of 3 (moderate) demonstrated a success rate (2 or greater grade drop) of 45.3% whereas patients with a baseline IGA grade of 4 (severe) demonstrated a success rate of 61.1%. Acne inflammatory lesion counts confirmed these results, with a reduction of at least 40% of lesions in 81.6% of treated hemifaces after 12 weeks. Treatment was considered as safe and well tolerated, with no serious adverse event and no patient discontinuation from the study from any adverse event. Patients' quality of life was also improved with a decrease of pain linked to acne after the 6-week treatment period. CONCLUSIONS: The BioPhotonic System comprised of LED blue-light phototherapy and photo-converter chromophores was found to be efficacious and safe, with a sustained clinical response at 12 weeks for the management of moderate to severe facial inflammatory acne.

Treatment of bromhidrosis with a glycine-soja sterocomplex topical product.

AIMS: Bromhidrosis is a common problem with a severe negative impact on the patient's social and emotional life. The objective of this open-label study was to evaluate the efficacy and safety of a local product with the main active ingredient of glycine-soja sterocomplex in the treatment of local bromhidrosis. PATIENTS/METHODS: Eighteen patients with axillary bromhidrosis and eight patients with bromhidrosis of the genital area were included. Bromhidrosis was evaluated through a sniff test of a worn garment on a four-point scale. Patients applied a glycine-soja sterocomplex topical agent twice daily on the affected areas for 15 days and bromhidrosis was evaluated again. RESULTS: Subjective mean level of bromhidrosis at baseline was 3.50 ± 0.50 and after treatment 1.53 ± 0.51. Mean impact on quality of life at baseline was 3.30 ± 0.48 and after treatment 1.30 ± 0.49. Investigators objective evaluation revealed an improvement in intensity of odor from 3.23 ± 0.83 to 1.53 ± 0.53 and in acceptability of odor from 3.1 ± 1.01 to 1.65 ± 0.76. CONCLUSIONS: The glycine-soja sterocomplex topical agent shows encouraging improvement on both the intensity and quality of odor in patients with bromhidrosis and has a profound improvement on the patients' quality of life without any side effects.