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.

Rupatadine effectively prevents the histamine-induced up regulation of histamine H1R and bradykinin B2R receptor gene expression in the rat paw.

BACKGROUND: Activation of histamine H1 receptor (H1R) is a well-known hallmark of allergic and inflammatory pathology. Both types of bradykinin receptors (B1R and B2R) are also known to contribute significantly to the latter and some sort of functional interaction between them and H1R has been alluded to in the past. Here we use an experimental model of rat paw oedema formation to examine the effect of exogenously added histamine on the gene expression of H1R and bradykinin receptors B1R and B2R, alone or in combination to rupatadine, a second generation antihistamine agent. METHODS: Histamine-induced oedema formation was monitored with a plethysmometer. The gene expression of H1R, B1R and B2R was analyzed with both conventional and real-time PCR. Rupatadine fumarate was used in pure form and administered intraperitoneally, prior to histamine injection into the paw. Microscopy of haematoxylin and eosin-stained sections of paw tissue was used to examine effects on tissue architecture. RESULTS: Histamine injection into the paw resulted in significant up regulation of H1R and B2R without inducing significant cellular infiltration, but appears to affect less the expression of B1R. Rupatadine was, under the conditions used in this study, very effective in preventing this effect and in suppressing oedema formation through its antihistamine action. CONCLUSION: Rupatadine has a suppressing effect on H1R and B2R gene expression which could add to its efficacy towards allergy and allergy-like conditions.

Metachronous occurrence of colorectal cancer in a muir-torre syndrome patient presenting with recurrent sebaceous adenoma of the eyelid: case report and updated review of the literature.

BACKGROUND: Muir-Torre syndrome (MTS) is a rare genodermatosis considered a subtype of hereditary nonpolyposis colorectal cancer and traditionally associated with mutations in the mismatch repair genes. OBJECTIVE: We describe a 51-year-old male with primary manifestations of recurrent sebaceous adenoma of the upper eyelid, a positive cancer family history, and metachronous occurrence of colorectal cancer. METHOD: The diagnosis of MTS was established based on the clinical course, family history, and histopathologic findings, although further immunohistologic testing revealed the absence of MSH2 mutation. We additionally performed an updated summary of published MTS cases with sebaceous neoplasms originating from the eyelid and conjunctiva for the period 2005 to 2011. CONCLUSION: This patient, the second Greek case described in the international literature, is of interest mainly because of the metachronous occurrence of the visceral malignancy in combination with the absence of MSH2 mutation. The need for high clinical suspicion for MTS in cases with sebaceous lesions of the periocular region should therefore be reinforced regardless of the mutational screening test undertaken.

Extrinsic aging: UV-mediated skin carcinogenesis.

Age-associated skin lesions linked to UV radiation (UVR) include actinic keratosis, non-melanoma skin cancer-such as basal cell carcinoma and squamous cell carcinoma-lentigo senilis and lentigo maligna. Their incidence is increasing worldwide, mainly due to exaggerated UV exposure and to an aging population. Early diagnosis and therapy of pre-malignant cutaneous lesions is crucial for the secondary prophylaxis of invasive and highly aggressive skin cancers. Combined efforts to increase public awareness, patient education about self-examination, prophylactic modalities, such as consistent and sufficient UV protection, and rigorous follow-up of high-risk groups are of highest importance.