Real-World Adverse Events Associated with Encapsulated Benzoyl Peroxide/Tretinoin, 3%/0.1%, and Encapsulated Benzoyl Peroxide, 5.

Encapsulated benzoyl peroxide, 5%, for rosacea and a combined formulation of encapsulated benzoyl peroxide/tretinoin, 3%/0.1%, for acne vulgaris, utilize microencapsulation, a process by which active pharmaceutical agents are enclosed in inert, permeable silica shells that provide a buffer between the drug and the skin. The silica shells allow a gradual release of the drug while also allowing combinations of active ingredients that would not otherwise be possible. This technology allows benzoyl peroxide and tretinoin to be combined in the same vehicle without risking the benzoyl peroxide-mediated oxidative destruction of tretinoin. In the current study, we queried the Galderma pharmacovigilance database to quantify and categorize adverse events associated with using these products in the USA during a 12-month period from May 2022 through April 2023. The adverse events were generally mild and restricted to local irritation, pruritus, burning sensation, and erythema. The real-world incidence and type of adverse events reported by the community for encapsulated benzoyl peroxide/tretinoin, 3%/0.1%, and benzoyl peroxide, 5%, were consistent with the safety and tolerability findings from the phase III clinical studies of these treatments.

Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study.

BACKGROUND: Atrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited. METHODS: In this randomized, split-face, double-blind study, subjects (age: 17-34 years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50 µg/g or vehicle once daily for 24 weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts. RESULTS: At week 24, a statistically significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count was noted in the trifarotene- vs vehicle-treated area (- 5.9 vs - 2.7; p < 0.0001) with differences between sides noted as early as week 2 (- 1.5 vs - 0.7; p = 0.0072). The SGA success rate was higher in the trifarotene side at week 12 (14.9% vs 5.0%, P < 0.05) and improved through week 24 (31.3% vs 8.1%, P < 0.001). Similarly, at week 24, the IGA success rate was higher with trifarotene (63.6% vs 31.3%, P < 0.0001) along with reductions in total (70% vs 45%) and inflammatory (76% vs 48%) lesion counts. The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity. CONCLUSIONS: Trifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar count as early as week 2. TRIAL REGISTRATION: Clinicaltrials.gov NCT04856904.

Medical Writing Competency Model - Section 1: Functions, Tasks, and Activities.

This article provides Section 1 of the 2017 Edition 2 Medical Writing Competency Model that describes the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry. The functions in the Model are scientific communication strategy; document preparation, development, and finalization; document project management; document template, standard, format, and style development and maintenance; outsourcing, alliance partner, and client management; knowledge, skill, ability, and behavior development and sharing; and process improvement. The full Model also includes Section 2, which covers the knowledge, skills, abilities, and behaviors needed for medical writers to be effective in their roles; Section 2 is presented in a companion article. Regulatory, publication, and other scientific writing as well as management of writing activities are covered. The Model was developed to aid medical writers and managers within the life sciences industry regarding medical writing hiring, training, expectation and goal setting, performance evaluation, career development, retention, and role value sharing to cross-functional partners.

Medical Writing Competency Model - Section 2: Knowledge, Skills, Abilities, and Behaviors.

This article provides Section 2 of the 2017 Edition 2 Medical Writing Competency Model that describes the knowledge, skills, abilities, and behaviors that professional medical writers need in order to perform effectively within the life sciences industry. What a medical writer should know, what they should be able to do, and how they should use this knowledge and these skills to facilitate their primary work function is a focus. Regulatory, publication, and other scientific writing as well as management of writing activities are covered. The full Model also includes Section 1, which covers the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry; Section 1 is included in a companion article. The Model was developed to aid medical writers and managers within the life sciences industry regarding medical writing hiring, training, expectation and goal setting, performance evaluation, career development, retention, and role value sharing to cross-functional partners.

Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes.

BACKGROUND: Acne affects individuals of all races and ethnicities; however, lighter and darker skin phototypes face different treatment challenges that may affect treatment response and tolerability. This analysis investigated possible differences in the efficacy and safety of the fixed dose combination of 0.3% adapalene with 2.5% benzoyl peroxide (A/BPO gel 0.3%/2.5%) in subjects with Fitzpatrick Skin Types (FST) I-VI.

METHODS: This was a post-hoc analysis of a Phase 3, multicenter, randomized, double-blind, parallel-group study of moderate to severe acne in subjects with FST I-VI. Subjects received A/BPO gel 0.3%/2.5%, A/BPO gel 0.1%/2.5% (benchmark), or vehicle, once daily for 12 weeks. Efficacy measurements included success rate (IGA of Clear or Almost Clear), change in inflammatory and noninflammatory lesions from baseline to week 12, safety, and tolerability. The intent to treat (ITT) and safety populations were analyzed. Demographics and disposition were analyzed with descriptive statistics; categorical variables by frequency and percentage; and continuous variables with means, medians, minimum, maximum, and standard deviations.

RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 128 subjects with FST I-III, and 89 subjects with FST IV-VI. At week 12, A/BPO gel 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle for all FST and severity groups in inflammatory and noninflammatory lesion reduction (P less than equal to .05). Compared to baseline, 32% of subjects with FST I-III were clear or almost clear, compared to 7% in the vehicle group (P=.001). In FST IV-VI, 28% of subjects were clear or almost clear, compared to 15% for vehicle (P=NS). In all treatment groups and skin phototypes, week 12 tolerability scores were similar to baseline scores, and tolerability scores for most subjects of all skin phototypes were "none" or "mild" for all measures.

SUMMARY: We report that the fixed dose combination of A/BPO gel 0.3%/2.5% is efficacious and safe in patients with FST I-VI with moderate and severe inflammatory acne.

Clinicaltrials.gov registry: NCT01880320

J Drugs Dermatol. 2017;16(6):574-581.

The renal vascular response to acutely elevated intrapelvic pressure: resistive index measurements in experimental urinary obstruction.

PURPOSE: To assess the accuracy of resistive index (RI) in the diagnosis of obstruction. MATERIALS AND METHODS: The time course of RI and its relationship to intrapelvic pressure were measured in 6 dogs following unilateral obstruction. RESULTS: Changes in RI 1) occurred as early as 1/2 hour after acute obstruction, 2) only reached diagnostic sensitivity after 3 to 4 hours, 3) accurately diagnosed obstruction whenever the RI ratio between the kidneys exceeded 1.15 and 4) were uninfluenced by alterations in intrapelvic pressure. CONCLUSIONS: Because RI more closely reflects changes in renal blood flow than pelvic pressure, it can accurately diagnose acute obstruction but only after several hours. Diagnostic accuracy in chronic obstruction may be influenced by these physiologic relationships.

Pancreas transplantation and dysuria.

Bladder drainage of the pancreatic graft remains the most common technique in pancreatic transplantation. Graft and patient survival is superior to duct injection and bowel drainage techniques. However, several urological complications develop as a result of bladder drainage. We report 6 cases of the dysuria syndrome after combined kidney/pancreas transplantation. Retrograde urethrography or cystoscopy showed extravasation from the bulbous urethra in all cases, which was most likely caused by activated proteolytic exocrine enzymes from the transplanted pancreas. Minor urethral trauma due to Foley catheterization or cystoscopy may predispose patients to this syndrome. Short-term urethral catheterization or suprapubic catheter drainage led to resolution in all cases. A high index of suspicion coupled with early intervention is recommended for patients with the dysuria syndrome.

Changes in testicular testosterone and acid and alkaline phosphatase activity in testis and accessory sex organs after induction of varicocele in Noble rats.

The present study was undertaken to determine the effects of surgically induced varicocele on testicular androgen production, seminiferous tubular diameter, and acid and alkaline phosphatase activities in testis and accessory sex organs in adult Noble rats. Testosterone concentrations in plasma and in both left and right testis were estimated in both sham-operated and varicocele-induced rats. The activities of acid and alkaline phosphatase were measured in both left and right testis, seminal vesicle, and ventral prostate gland in varicocele-induced and sham-operated rats. The levels of testosterone in plasma in rats with varicocele were lower than those in the sham-operated rats. The concentration of testosterone in the left testis was lower than that in the right testis in varicocele-induced rats while no such differences were observed in sham-operated rats. The seminiferous tubular diameter in the left testis is reduced in varicocele-induced rats from that in the right testis. In the sham animals, testicular acid phosphatase activity was higher in the left testis than the right, while in varicocele-induced animals, no differences in acid phosphatase activity between left and right testis were observed. In varicocele-created rats, the activity of alkaline phosphatase was higher in the left testis than in the right while no differences in alkaline phosphatase activity between left and right testis in sham-operated rats were observed.(ABSTRACT TRUNCATED AT 250 WORDS)

Testicular torsion and its effects on contralateral testicle.

Twenty-six male adult Noble (Nb) rats underwent unilateral left testicular torsion of 720 degrees. The testicles of the 6 control animals were immediately detorsed. The experimental animals were divided into 4 groups according to the surgical approach (abdominal vs. scrotal) and location where the torsed testicle was placed (abdomen vs. scrotum). After six hours all torsed testicles in the experimental groups were detorsed. One month later all animals were sacrificed, and the contralateral testicles were examined for spermatogenesis and mean seminiferous tubular diameter. All groups displayed decreased spermatogenesis with smaller mean seminiferous tubular diameter as compared with the control group.

Prostate-specific antigen, digital rectal examination, and transrectal ultrasound in predicting the probability of cancer.

Over a 4 1/2 year period, 1,940 asymptomatic men were entered in a prostate cancer detection program consisting of digital rectal examination (DRE), prostate-specific antigen (PSA), and transrectal prostate ultrasound (TRUS). Four hundred and sixteen biopsies were performed resulting in the diagnosis of 79 cancers; 82% had clinically organ confined tumors. A recommendation for biopsy was made in 260 (62%) based on the TRUS alone, 55 (13%) by DRE alone, 92 (22%) when the DRE and TRUS were both abnormal, and in 9 (2.2%) cases when only PSA levels were elevated. The DRE, PSA, and TRUS were abnormal in 1,261 (65%), 989 (51%), and 1,552 (80%) of the patients with cancer, respectively. Prostate cancer detection increased as the serum PSA level increased above 4 ng/ml. The positive predictive value of both DRE and TRUS were significantly influenced by an elevated PSA, (P = .042 and P less than .00005, respectively). The results of this study support the idea that, although the prostate cancer detection rate is influenced by these three modalities and the detection rate of localized disease can be improved by early detection programs, its effect on mortality rates remains undefined at this time.

Radical prostatectomy: OSU and affiliated hospitals' experience 1985-1989.

A total of 528 patients have been treated with radical prostatectomy and node dissection during the last five years. Correlation of clinical and pathologic staging will be presented. Over 85 percent of these patients had Gleason scores of 6 or less. Patients who had nerve-sparing surgery had a potency rate of over 60 percent post surgery.

Two year experience with transrectal prostate ultrasound.

During the last two and a half years, transrectal prostate ultrasound has been used extensively at our institution. Three hundred and twenty patients have been evaluated in a double blind fashion as part of a study comparing digital rectal examination and transrectal prostatic ultrasound. Prostate cancer was detected in twenty three patients (7.2%); 13 had palpable nodules (4.1%) and 10 had non-palpable nodules (3.1%). Of the 23 patients, 19 had clinically localized (Stage B) prostate cancer. Clinical and pathologic staging correlated in 15 patients (79%). This compares favorably to clinical staging accuracy of 55% in patients prior to utilization of transrectal prostatic ultrasound.

Radical nerve-sparing prostatectomy with epidural anaesthesia in 100 patients.

From August 1985 to January 1989, 100 patients were treated with radical nerve-sparing prostatectomy with epidural anaesthesia. Transrectal ultrasound evaluation was available for most of these patients. Using the anatomical techniques of early dorsal vein ligation, hypogastric artery control and epidural anaesthesia, blood loss was minimised and 55 patients required no transfusions. In addition, with the use of ultrasound, PSA determination and pelvic CAT scan, 73 of these 100 patients had organ-confined disease; 66 patients were potent pre-operatively and 42 are potent post-operatively.

The role of the adrenal in the rat varicocele model.

Sexually mature male Nb rats were subjected to left sided unilateral varicocele ligation. A control (sham surgery) group and experimental groups of concomitant ipsilateral adrenalectomy or delayed ipsilateral nephrectomy were constructed. Sperm motility, intratesticular testosterone concentration, testicular temperature and light microscopic histologic changes were ascertained eight weeks after the surgical procedure. Marked depression of intratesticular testosterone and sperm motility were noted in the varicocele and the varicocele plus nephrectomy groups. The varicocele plus ipsilateral adrenalectomy group showed no statistical changes in these parameters from the control (Sham) group. No significant alterations in testicular histology were noted between groups. These data tend to implicate an alteration in adrenal function or blood flow as an etiologic agent in the testicular alterations induced by the rat varicocele model.

Sports and the Male Genitourinary System.

In brief: Contusions and minor lacerations, the most common renal injuries, require conservative treatment, and the athlete must refrain from strenuous activities for 2 to 3 weeks. Most patients with hematuria have a renal contusion at most and do not need contrast studies. Underlying renal abnormalities, pyelonephritis, and stone disease are occasionally seen. Patients who have gross hematuria after strenuous jogging or marathons should not run with an empty bladder. The smoke- or tea-colored urine that occurs after athletic endeavors usually resolves without sequelae within 24 hours and requires no further evaluation.

Sports and the Male Genitourinary System.

In brief Most injuries to the penis and scrotum in sports result from direct blows and require prompt evaluation. Bicycler's penis is a paresthesia and numbness in the perineum and phallus that resolve spontaneously. A direct blow to the scrotum usually causes a testicular contusion that responds to elevation of the scrotum and bed rest. Athletes wear athletic supporters and plastic cups for scrotal protection. Sexually transmitted diseases-nongonococcal urethritis, condyloma acuminatum, and herpes progenitalis-are common urologic problems in athletes. Patients should use condoms or abstain from sexual activity until the condition resolves.

Relative value of prostate-specific antigen and prostatic acid phosphatase in diagnosis and management of adenocarcinoma of prostate. Ohio State University experience.

Serum concentrations of prostate-specific antigen (PSA), prostate-specific acid phosphatase (PAP), and transrectal prostatic ultrasound were utilized in the evaluation of 193 men with various urologic disorders. Of the 193 patients, 48 had prostate cancer, and the other 145 included 5 with genitourinary neoplasms, 69 with benign prostatic hypertrophy, and 71 with other non-neoplastic genitourinary disease. PSA levels were elevated in 35 patients with prostate cancer and in 25 of the 145 without prostate cancer. PAP levels were elevated in 15 with prostate cancer and in 2 of the 145 without prostate cancer. The data indicate that PSA is a more sensitive but less specific tumor marker than PAP in the detection of prostate cancer. PSA appears to be more sensitive than PAP in monitoring the response to treatment. The use of PSA and PAP jointly to detect and to monitor prostate cancer did not appear to enhance the clinical utility over that of PSA alone.