Efficacy and safety of a hydrocortisone aceponate-containing ear spray solution in dogs with erythemato-ceruminous otitis externa: A randomised, multicentric, single-blinded, controlled trial.

BACKGROUND: Erythemato-ceruminous otitis externa (ECOE) is frequently seen in dogs affected with an allergic skin disease, with recurrent secondary bacteria and yeast overgrowths (detected on cytological examination). OBJECTIVES: The objective of the study was to compare the efficacy and safety of an ear spray containing only hydrocortisone aceponate glucocorticoid diester (HCA) to a control product (CTRL), an approved otic formulation containing prednisolone-miconazole-polymyxin combination, in dogs with ECOE. ANIMALS: In total, 97 and 104 dogs with ECOE were respectively randomly assigned to the tested ear treatment product group (HCA) or the commercially available ear treatment control product group (CTRL). MATERIALS AND METHODS: Dogs were treated for 7-14 days, as needed. At Day (D)0, D7, D14, D28 and D42, Otitis Index Score-3, hearing test, pruritus and pain visual analogue scales, and cytological scores were graded. The overall response to treatment also was assessed. RESULTS: All clinical parameters decreased rapidly and in a similar way without any significant difference at any time between treatment groups. A good-to-excellent response to treatment was seen in >90% of dogs of both groups as early as D14. The treatment was considered safe in all dogs. CONCLUSIONS AND CLINICAL RELEVANCE: A 7- to 14-day ear topical application of HCA alone to dogs with ECOE accompanied with bacterial and/or fungal (yeast) overgrowth was safe and led to no statistical difference in improvement of clinical scores relative to the CTRL combination. Based on these results, it may be necessary to reconsider the routine use of antimicrobial drugs such as antibiotics and antifungals as a first-line treatment for ECOE that is likely to have been caused by an allergic reaction.

Efficacy and Safety of 4.7 mg Deslorelin Acetate Implants as a Neutering Option in Male Cats: A Large-Scale Multicentre Randomised Controlled Study.

This multicenter-controlled, double-masked randomized European study was conduc-ted to confirm both the efficacy and safety of a deslorelin implant in controlling fertility and sexual behavior in a large population of tom cats over a 12-month period. Among the 225 screened individuals, a total of 205 privately owned indoor intact male cats, aged 3 months of age or older, were randomly allocated to a deslorelin implant (n = 154) or to a negative control group (n = 51). After the screening visit performed between day (D)-14 and D-7, six additional visits were sche-duled on D0, D45, D93, D186, D279 and D372. Effects on testosterone, sexual behaviors, penile spines, testicular volume and intact male cat urine odor were assessed at every visit under masked conditions as regards to the treatment group. In addition, phone calls from the investigators to the owners were scheduled on D7 and then on a monthly basis whenever no visit was scheduled. Success was defined as an individual serum testosterone concentration below or equal to 0.10 ng/mL and was 77.9% at D45, 83.1% at D93, 84.4% at D186 and D279, and 61.7% at D372 in the deslorelin group, and 3.9% at D45, 5.9% at D93, 3.9% at D186, 7.8% at D279 and 3.9% at D372 in the negative control group. Testing for superiority was made stepwise from D45 to D372 upwards; the difference in success rates was significant from D45 to D372 (p < 0.001 for each time point). The mean testosterone concentration dropped from baseline in the deslorelin group, remaining below the set threshold of 0.1 ng/mL until D372. From D7 onwards, the mean sum score for sexual behaviors (including vocalization, urine marking, aggression and intact male cat urine odor) was significantly lower at each observation time point in the deslorelin group compared to the control group, where no decrease in scores was observed. The mean percent change to baseline of the testicular volume and the percentage of cats with a decreased visibility and adult appearance of penile spines were significantly lower in the deslorelin group as soon as D45. No relevant safety concerns were reported during the course of the study. The deslorelin implant Suprelorin® 4.7 mg (Virbac, Carros, France) is a safe and effective neutering option, inducing infertility over a 12-month period when administered to intact male cats aged between 3 months of age and 11 years of age. The implants also successfully reduced sexual behaviors (i.e., vocalization, urine marking, aggression), intact male cat urine odor, testicular volume and penile spine score for 1 year (372 ± 5 days).

Efficacy and Safety of 4.7 mg Deslorelin Acetate Implants in Suppressing Oestrus Cycle in Prepubertal Female Dogs.

Our multicentric, masked, controlled and randomised study aimed to assess the efficacy and safety of Suprelorin® 4.7 mg (Virbac, Carros, France) regarding oestrus prevention in prepubertal intact bitches. Twelve- to eighteen-week-old females (n = 83) were allocated either a deslorelin implant (n = 62) or 0.9% sodium chloride (n = 21) group. Clinical assessment (heat signs), 17ß oestradiol and progesterone assays, and vaginal cytology were performed at day (D)0, D7, D21, month (M)3 and M6 after product administration, and were then performed every other month until reaching puberty. Trained owners assessed heat signs between each veterinary visit. All bitches (n = 83) reached puberty before M30. Deslorelin significantly extended the median time to sexual maturity when compared to the control group (377 days versus 217 days after D0, p < 0.0001). Three females, implanted between 16 and 18 weeks of age, expressed an induced oestrus. Additional descriptive data, collected over a 24 month-period, showed functional reproductive abilities in both deslorelin (n = 52) and control (n = 21) groups once puberty was achieved. In conclusion, Suprelorin® 4.7 mg seems to be an effective and safe option for postponing the onset of oestrus when administered to prepubertal female dogs aged from 12 to 16 weeks.

Superior Efficacy with Ivermectin 1% Cream Compared to Metronidazole 0.75% Cream Contributes to a Better Quality of Life in Patients with Severe Papulopustular Rosacea: A Subanalysis of the Randomized, Investigator-Blinded ATTRACT Study.

INTRODUCTION: Ivermectin 1% cream (IVM 1%) is indicated for the treatment of inflammatory lesions of rosacea. The objective of this subanalysis was to compare IVM 1% vs. metronidazole 0.75% cream (MTZ 0.75%) in the treatment of severe inflammatory lesions of rosacea. METHODS: A subanalysis of the investigator-assessed severe subjects from a Phase 3, investigator-blinded, randomized study comparing IVM 1% once daily (QD) with MTZ 0.75% twice daily (BID) over 16 weeks followed by a 36-week extension period was performed. Efficacy assessments were Dermatology Life Quality Index (DLQI) and EuroQol-5 Dimension (EQ-5D) questionnaires, investigator's global assessment (IGA), subject assessment of rosacea improvement, and inflammatory lesion counts. Adverse events (AEs) were monitored throughout the study. RESULTS: A total of 161 subjects (16.7% of overall study population; 80 IVM 1% and 81 MTZ 0.75%) had an IGA score of 4 at baseline representing severe papulopustular rosacea. Significantly more IVM 1% subjects had a minimal clinically important difference (MCID, defined as a decrease from baseline of ≥4 points) in DLQI score than MTZ 0.75% subjects at week 16 (65.4% vs. 39.2%; P = 0.001) and week 52 (68.8% vs. 40.4%; P = 0.003). At week 16, the mean EQ-5D score for the IVM 1% subjects was higher (better quality of life) than for MTZ 0.75% subjects (0.941 vs. 0.896). Significantly more IVM 1% subjects were IGA "clear" or "almost clear" at week 16 compared to MTZ 0.75% (82.5% vs. 63.0%; P = 0.005). Incidence of AEs was comparable between groups. CONCLUSION: Better efficacy with IVM 1% cream (QD) compared to MTZ 0.75% cream (BID) contributes to an improved quality of life with significantly more patients achieving an MCID in DLQI score at week 16 and higher mean EQ-5D score. IVM 1% cream is thus a better alternative than MTZ 0.75% cream for severe papulopustular rosacea patients. TRIAL REGISTRATION: EUDRACT number: 2011-004791-11. FUNDING: Galderma R&D.

Exploratory clinical trial to evaluate the efficacy of a topical traditional chinese herbal medicine in psoriasis vulgaris.

Objective. To evaluate the efficacy and safety of herbal ointment, Shi Du Ruan Gao, in patients with plaque-type psoriasis. Design. Single-center, randomized, investigator-blinded, parallel group, placebo-controlled study. Participants. One hundred outpatients with mild to moderate chronic plaque-type psoriasis were enrolled. Intervention. The patients applied either Shi Du Ruan Gao ointment or vehicle ointment topically to for 8 weeks. Main Outcome Measures. The outcomes were assessed using the following criteria: Total Severity Score (TSS, sum of erythema, scaling, and plaque elevation/induration, on a 0 to 4 scale), Investigator Global Assessment (IGA) evaluated on a 0 (Clear) to 4 (s to very severe) scale, and Global Subjects' Assessment of treatment response on a 7-point scale from -1 (worse) to 5 (Cleared). Results. Significant reductions in the Total Severity Score (P < 0.001) (mean score: 2.7 after Shi Du Ruan Gao treatment versus 5.1 in control subjects). Both Investigator Global Assessment (IGA) and Global Subjects' Assessment of treatment are better in the Shi Du Ruan Gao group than the control group (P < 0.001). Conclusion. Shi Du Ruan Gao ointment was a safe, and effective therapy for plaque-type psoriasis.

Adapalene gel 0.1% is better tolerated than tretinoin gel 0.025% among healthy volunteers of various ethnic origins.

BACKGROUND: The efficacious acne treatment adapalene gel 0.1% is significantly less irritating than tretinoin of various concentrations and formulations, according to several clinical studies conducted predominantly in Caucasian patients. OBJECTIVES: To confirm the lower irritation potential of adapalene gel 0.1% compared to tretinoin gel 0.025% among volunteers of various ethnic origins and to explore the difference in the irritant susceptibility among ethnic groups. METHODS: The study was a single-centre, randomized, investigator-masked and intra-individual comparison. Healthy volunteers applied adapalene and tretinoin daily to the face for 21 days and to the forearms for 4 days, and were then evaluated for the level of irritation. RESULTS: The irritation potential of adapalene gel 0.1% was significantly lower than that of tretinoin gel 0.025% in all tolerability assessments, irrespective of the volunteers' ethnic origins. The between-treatment differences were similar among various ethnic groups. Statistically significant but small inter-ethnicity differences were observed in the evaluation of facial signs, with Caucasians being less susceptible than Chinese, Asian Indians and Malays. CONCLUSION: Adapalene gel 0.1% was significantly better tolerated than tretinoin gel 0.025% among various ethnic groups. The patients' ethnic origins had no impact on the difference between adapalene and tretinoin treatments in terms of tolerability.

Calcitriol ointment 3 microg/g is safe and effective over 52 weeks for the treatment of mild to moderate plaque psoriasis.

Topical vitamin D3 agents have emerged as important options for the treatment of psoriasis. Calcitriol, a naturally occurring and biologically active form of vitamin D3, has been developed in an ointment formulation for topical psoriasis therapy in the United States. The product has been used outside of the United States for years. Several short-term (< 6 months) clinical trials have demonstrated that calcitriol ointment 3 microg/g improves symptoms of psoriasis in participants with mild to moderate plaque psoriasis without demonstrating clinical evidence of alterations in calcium homeostasis, but little information has been available about the safety and effectiveness of continuous long-term use of calcitriol ointment. In this open-label, multicenter study, 324 participants with primarily mild to moderate chronic plaque psoriasis were treated with calcitriol ointment 3 microg/g twice daily for up to 52 weeks. A total of 136 participants completed 52 weeks of treatment. Serious adverse events (AEs) (reported by 1 participant each unless otherwise noted) included a pretibial skin ulcer (study drug was used only on the upper body), a joint disorder, metrorrhagia (2 participants), heart failure, hospitalization due to arteriosclerosis, breast carcinoma, and an infection (due to a dog bite). Clinical improvement in psoriasis symptoms was assessed by an investigator-rated global severity score (GSS) and participant-rated global assessment of improvement in psoriasis symptoms from baseline. Improvements in GSS were seen over the course of treatment. Calcitriol ointment 3 microg/g is a safe, effective, and well-tolerated option for the long-term treatment of chronic plaque psoriasis. Clinical improvement was maintained for up to 52 weeks, with no clinical effect on calcium homeostasis or other relevant laboratory test parameters.

Is combined oral and topical therapy better than oral therapy alone in patients with moderate to moderately severe acne vulgaris? A comparison of the efficacy and safety of lymecycline plus adapalene gel 0.1%, versus lymecycline plus gel vehicle.

This multicenter, randomized, investigator-blinded study compared the efficacy and tolerability of a combination of lymecycline 300 mg/day orally and adapalene topical gel 0.1% (n = 118) to lymecycline 300 mg/day orally plus vehicle gel (n = 124) in patients with moderate to moderately severe acne vulgaris with both inflammatory and noninflammatory lesions. The primary efficacy end point, total lesion count at end point (last observation carried forward), showed a statistically significant difference in favor of the lymecycline plus adapalene group (P =.0011). The mean decrease in total, inflammatory and noninflammatory lesion counts was significantly greater at end point in the lymecycline plus adapalene group than in the lymecycline plus vehicle group (P <.01). In addition, a significant difference for inflammatory and total acne lesions was seen sooner in the adapalene plus lymecycline group. In total, 75.5% of patients in the lymecycline plus adapalene group were markedly improved, almost clear or clear of their lesions at week 12, compared with 51.8% of those in the lymecycline plus vehicle group (P <.001). Local cutaneous tolerance was generally good in both groups, although more patients receiving the lymecycline plus adapalene combination experienced cutaneous reactions than those receiving lymecycline plus vehicle. There are relatively few studies comparing the efficacy of combined oral and topical therapy with either individual therapy alone. This study clearly demonstrates that lymecycline plus adapalene combination treatment resulted in a significantly greater mean decrease in the number of inflammatory, noninflammatory and total lesions than lymecycline plus vehicle and was well tolerated.