Investigating the impact of added Profhilo mesogel to subcision versus subcision monotherapy in treating acne scars; a single-blinded, split-face randomized trial.

BACKGROUND: Acne scar is an inflammatory condition, which commonly occurs in patients with acne vulgaris, especially in adults. Mesogels have been reported effective in improving atrophic acne scars. AIMS: We investigated the efficacy of adding Profhilo (a hyaluronic acid-based filler) to subcision as a new treatment method. METHODS: Twelve patients aged 18-45 years with atrophic acne scars on both sides of the face participated in this single-blinded, split-face, randomized controlled trial. Each side of the face was randomly assigned to one of the treatment methods, including subcision alone and subcision + Profhilo. Patients in the Profhilo arm received mesogel (1 cc) in addition to the subcision procedure. Both methods were carried out two times at 1-month intervals. Assessments were done based on the sonographic depth of scars, and two blinded observers examined photographs at baseline and 3 months after the final session and the results were reported based on an exclusively made formula as the total score. The Global Improvement Scale and Visual Analogue Scale (VAS) (for patient satisfaction) were also used. RESULTS: The VAS score of patient satisfaction was statistically significant in the Profhilo arm, with a mean improvement of 528.08 and 219.06 in the subcision arm (p = 0.02). No significant difference was seen in total acne scar reduction comparing the two methods (29.74 in the Profhilo arm and 22.27 in the subcision arm, p = 0.56). Sonographic depth reduction was also non-significant, with a mean of 29.21 in the Profhilo arm and 28.53 in the subcision arm (p = 0.4). The mean global improvement was reported as four in both arms, and no statistical significance was observed (p = 0.89). The best response to treatment belonged to the rolling subtype in both methods (p = 0.029 for the Profhilo arm and p = 0.001 for the subcision arm). CONCLUSION: Despite no significant difference between the methods, Profhilo is more effective due to a higher satisfaction rate and better physiologic effects.

Evaluation of the safety and efficacy of a biosimilar abobotulinum toxin type A in treating moderate-to-severe glabellar lines: A non-inferiority double blinded randomized controlled trial.

BACKGROUND: Injection of botulinum toxin for cosmetic purposes is a well-established practice. OBJECTIVES: This study was conducted to compare the safety and efficacy of Dyston® (investigational biosimilar abobotulinumtoxinA) with Dysport® (abobotulinumtoxinA, Ipsen) in the treatment of moderate-to-severe glabellar lines. METHODS: Out of 193 screened subjects, 126 volunteers with moderate-to-severe glabellar lines fulfilling eligibility criteria were randomized in a 1:1 ratio to receive either an intramuscular injection of 40-60 units of Dyston® or Dysport® . The primary objective was to test the non-inferiority of Dyston® compared with Dysport® as measured by the percentage of volunteers who achieved no or mild glabellar lines at maximum frown assessed by the physicians based on the Glabellar Line Severity Score (GLSS) at Day 30. Secondary endpoints included the improvement in the glabellar lines at maximum frown and rest states at Days 14, 60, 90, and 120 as well as the side effects of the treatment. RESULTS: Response rates at maximum frown were 75.44% (43/57) in the Dyston® group and 76.67% (46/60) in the Dysport® group on Day 30 (p value: 0.88, 95% CI: -14.24 to 16.70, diff: 1.23) as per-protocol set, and were 75.81% (47/62) and 76.19 (48/63) (p value: 0.96, 95% CI: -14.59 to 15.35, diff: 0.3) in the Dyston® and the Dysport® groups, respectively, based on modified intention to treat population. Adverse events were similar in both groups and mostly mild and well-tolerated. CONCLUSION: Treatment of moderate-to-severe glabellar lines with Dyston® was effective, tolerable, and non-inferior compared with Dysport® .

Assessment of the Efficacy and Safety of Hyaluronic Acid Gel Injection in the Restoration of Fullness of the Upper Lips.

BACKGROUND AND AIM: Lips have a significant role in face aesthetic perception, and lip augmentation is one of the most commonly requested aesthetic procedures. Non-permanent dermal fillers, such as hyaluronic acid (HA), are used for augmenting the lips. This article presents the results of Phase II, before - after designed study, assessing the safety and efficacy of a soft tissue HA filler, for upper lip augmentation. MATERIALS AND METHODS: Investigators treated 10 healthy adult women 28-45 years old, using a single injection of Hyamax Kiss soft tissue HA filler (a product from Hyamed Laboratories, Switzerland) for upper lip augmentation. The primary efficacy endpoint was an increase in lip fullness at least one grade on Medicis Lip Fullness Scale at 2, 12 and 24 weeks post-treatment. Furthermore, the effectiveness and durability of filler were assessed using a 5-point Investigator's Global Assessment (IGA). Adverse events and volunteers' satisfaction were reported using visual analog scale. RESULTS: Response to treatment (as defined above) after 2, 12 and 24 weeks were observed in 80%, 70% and 80% of patients, respectively. No statistical difference was found in response to treatment rate between follow-up visits (P = 0.83). The mean value of IGA score in weeks 2, 12 and 24 were 3.4 ± 0.96, 3.3 ± 0.67 and 3.3 ± 0.67, respectively. The study subjects were almost all satisfied with their lip improvement. Reported adverse effects were temporary and mostly mild in severity. CONCLUSION: Soft tissue HA filler tested in this study was well tolerated, efficient and durable when used for upper lip augmentation.

Safety Assessment of Tretinoin Loaded Nano Emulsion and Nanostructured Lipid Carriers: A Non-invasive Trial on Human Volunteers.

BACKGROUND AND AIM: Topical application of tretinoin (TRE) is followed by a high incidence of side effects. One method to overcome the problem is loading TRE into lipid nanoparticles. The potential safety of the nanoparticle materials has been always considered as a major concern. In this in vivo study, changes in human skin biophysical parameters including hydration, TEWL, erythema, and pH have been used to determine the safety of tretinoin loaded nano emulsion (NE) and nanostructured lipid carriers (NLC). METHOD: TRE loaded NE and NLC were prepared using a high pressure homogenizer. Skin biophysical parameters were measured on the volar forearms of twenty healthy volunteers, before and after applying TRE-NE and TRE-NLC lotions. All the measurements were done using respective probes of MPA 580Cutometer®. RESULT: We obtained particles of nanometric size (<130 nm) with narrow distribution and optimal physical stability. None of the formulations made any statistically significant change in any of the measured skin properties. P-values were 0.646, 0.139, 0.386, 0.169 after applying TRE-NE and 0.508, 0.051, 0.139, 0.333 after applying TRE-NLC, respectively. CONCLUSION: Both formulations are reasonably safe to apply on human skin and topical application of TRE-NE and TRE-NLC had almost similar effects on skin biophysical parameters.

Treatment of acute cutaneous leishmaniasis with intralesional injection of meglumine antimoniate: comparison of conventional technique with mesotherapy gun.

BACKGROUND: The gold standard treatment of Old World leishmaniasis, a common tropical parasitic infestation, is intralesional meglumine antimoniate injection. Mesotherapy is a new minimally invasive method of administration of variable substances to the skin. OBJECTIVE: Comparison of the efficacy and adverse effects of treatment of leishmaniasis with intralesional injection of meglumine antimoniate using conventional method and mesotherapy method. PATIENTS AND METHODS: Eighty-five patients with proven leishmaniasis were recruited and randomly treated by one of the two methods, either by conventional injection or by mesotherapy administration weekly. Lesion characteristics were evaluated at every treatment session as well as 1 week, 1 month and 3 months after cessation of treatment. RESULTS: The improvement in lesions was similar in both groups, while it was noted sooner in mesotherapy group with less amount of drug usage (P = 0.005 and 0.016 respectively). Also, patients treated with mesotherapy experienced less pain severity (P = 0.005). CONCLUSION: Mesotherapy is a safe and effective method of meglumine antimoniate injection for the treatment of cutaneous leishmaniasis and is less painful.

Evaluation of meglumine antimoniate effects on liver, kidney and pancreas function tests in patients with cutaneous leishmaniasis.

Cutaneous leishmaniasis has been recognized as a major public health problem in several countries. Pentavalent antimonies, meglumine antimoniate and sodium stibogluconate, have been considered as standard treatment for leishmaniasis. Side effects have been reported to be increased hepatic enzyme levels and electrocardiographic abnormalities. We performed this study to evaluate the influence of meglumine antimoniate on some liver, kidney, and pancreas function tests. Eighty patients fulfilled the study criteria. Forty-one (51.3%) patients were female and the mean age of the patients was 30.4 +/- 15.7 years. Blood samples were taken to evaluate liver, kidney, and pancreas function tests before and after treatment with intramuscular injections of MA at a dose of 20 mg Sb(+5)/kg/day for 15 days. Mean serum levels of blood urea nitrogen, creatinine, sodium, total and direct bilirubin, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase significantly increased after treatment, although most of them were within normal ranges. There were no significant differences in serum levels of potassium, amylase, lipase, and gamma-glutamyl transpeptidase before and after treatment. In conclusion it can be stated that one course of treatment with 20 mg Sb(+5)/kg/day MA for 15 days does not significantly alter the liver, kidney and pancreas function tests in patients with cutaneous Leishmaniasis.

Treatment of traumatic tattoo with the Q-switched Nd:YAG laser.

Traumatic tattoos are undesirable tattoos caused by different foreign bodies such as fireworks' particles, sand, metals, glass, gunpowder, asphalt, dust, or petroleum products embedded forcefully in the dermis. We report the case of a 54-year-old man who presented with sand and asphalt tattooing on his face following a bomb explosion 15 years ago. Q-switched Nd:YAG laser at a wavelength of 1064 nm with a spot size of 4 mm and a fluence of 7.96 J/cm(2) were applied to treat the patient. The patient tolerated the treatment very well. Most of the blue dots became whitened immediately after the procedure and remained almost clear after a 6-month follow-up.

Allergic contact dermatitis in Iran.

The frequency of sensitization to contact allergens varies in different countries because of both genetic and, more importantly, allergen exposure variations. The objective is to determine the frequency of sensitization to contact allergens in Iranian patients with dermatitis. 250 patients with a clinical diagnosis of contact dermatitis and/or atopic dermatitis were evaluated with a 28-allergen screening series recommended by the German Contact Dermatitis Research Group from September 2002 to April 2004 in Tehran, Iran. The patches were applied on the back of the patients, removed after 24 hr and the readings were taken on 24 hr, 48 hr and 72 hr after application. 126 patients (50.4%) showed at least 1 positive reaction, and 23 patients (9.2%) had more than 2 positive reactions. 189 (84.4%) of 224 positive reactions had past and/or present clinical relevance. The 5 most common allergens were nickel sulfate 70 (28.0%), cobalt chloride 32 (12.8%), para-tertiarybutyl phenol formaldehyde resin 20 (8.0%), potassium dichromate 13 (5.2%) and colophony 13 (5.2%). Contact allergy to nickel sulfate was significantly more common in female patients and in patients under 40 years of age (P < 0.05). Nickel sulfate is the most common contact allergen in Iran, mostly affecting women and younger patients probably because of more exposure.