Publications by authors named "Leon H Kircik"
Article Synopsis
- Topical clindamycin phosphate/adapalene/benzoyl peroxide (CAB) gel is approved for treating acne in patients 12 and older, and post hoc analyses examined its effectiveness in younger patients with acne.
- Data from two studies showed that CAB significantly improved treatment success and reduced acne lesions in adolescents compared to a vehicle gel, with 51.5% of treated adolescents achieving success versus 24.9% with the vehicle.
- The CAB gel was generally well tolerated, with most adverse events being mild to moderate, and it was effective for younger children as well, with significant lesion reductions observed in all treated children.
Article Synopsis
- Topical CAB gel, a combination of clindamycin phosphate, adapalene, and benzoyl peroxide, is the only approved treatment for moderate-to-severe acne using a triple formulation, showing superior results in clinical studies compared to individual components.
- In two phase 3 studies, participants aged 9 and older were treated with CAB or a placebo, resulting in over 70% reduction in acne lesions for all CAB-treated cases by week 12, with most achieving clear skin or a notable reduction in severity.
- Overall findings indicated CAB is effective and well-tolerated, emphasizing the need for patient education on adherence and managing expectations regarding side effects.
Article Synopsis
- Safe and effective long-term topical treatments for atopic dermatitis (AD) are limited, leading to low adherence rates among patients.
- The study aimed to assess the efficacy and safety of once-daily roflumilast cream (0.15%) compared to a vehicle cream in patients aged 6 and older with mild to moderate AD across two phase 3 trials.
- Results showed that a significantly higher percentage of patients using roflumilast achieved treatment success and a notable reduction in eczema severity compared to those using the vehicle cream.
Background: The combined use of topical calcipotriol/betamethasone dipropionate (Cal/BDP) is commonly used and demonstrated to be effective for the management of psoriasis and is shown to confer local anti-inflammatory and immunoregulatory effects. The use of the two agents in combination is synergistic. Despite the demonstrated efficacy of topically applied combination Cal/BDP, successful management of a chronic, relapsing inflammatory skin disease such as psoriasis in the real-world setting may be hindered if patients do not adhere to the dosing or frequency of application recommendations from their prescriber.
View Article and Find Full Text PDFArticle Synopsis
- * In a 12-week double-blind study involving over 360 participants aged 9 and older, CAB led to a 50% success rate in achieving clear skin, significantly outperforming a placebo gel, with over 70% reduction in both inflammatory and non-inflammatory acne lesions.
- * The treatment showed a good safety profile, with only mild to moderate side effects and a low discontinuation rate due to adverse events, indicating CAB could be a promising option for those suffering from moderate
Article Synopsis
- Topical psoriasis treatments often have limited efficacy and safety, prompting a study on roflumilast cream's long-term effects.
- In a phase 2 trial with 332 adult psoriasis patients, those who applied roflumilast cream daily for 52 weeks showed a high completion rate and only minimal adverse events.
- Results indicated that the cream was effective, with about 44.8% of patients achieving significant improvement at Week 52, supporting its use for chronic treatment, including sensitive areas like the face.
Article Synopsis
- - The study shows that a once-daily, three-in-one topical acne treatment (CAB gel) combining an antibiotic, antibacterial, and retinoid leads to faster and greater improvements in acne lesions compared to dual combinations or vehicle gel.
- - In phase 2 and phase 3 trials, CAB gel users saw significant reductions in both inflammatory and noninflammatory acne lesions as early as week 4, with better results sustained over 12 weeks.
- - By the end of the 12-week treatment, a higher percentage of participants using CAB gel achieved significant reductions in their acne compared to those using other combinations or placebo treatments.
Antibiotics, topical and oral, are a cornerstone in the treatment of acnes vulgaris specifically by targeting the skin bacterium Cutibacterium acnes. Billions of individuals have received antibiotics as part of their treatment resulting in a worldwide pandemic of antibiotic resistance not only for C. acnes but also many other pathogens.
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- Topical acne trials face challenges from high responses to placebo treatments and varied outcome measures, complicating treatment comparisons; number needed to treat (NNT) offers a straightforward way to evaluate effectiveness indirectly.
- Among 13 acne treatments analyzed, the effectiveness varied significantly, with a triple-combination gel showing the highest treatment success rates, leading to favorable NNTs of 4 and 5.
- The study concludes that using consistent outcome measures and similar patient demographics highlights triple-combination gel and adapalene/BPO gel as the most effective options based on NNT results.
Background: Using a three-pronged acne treatment approach-combining an antibiotic, antimicrobial agent, and retinoid-may provide greater efficacy than monad or dyad treatments. Herein are the dermal sensitization, irritation, safety, and tolerability results from phase 1 and 2 studies of fixed-dose clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.
View Article and Find Full Text PDFBackground: Scalp psoriasis affects most patients with psoriasis, but it can be difficult to treat.
Objectives: To evaluate the efficacy and safety of once-daily roflumilast foam 0.3% on scalp and body psoriasis.
Article Synopsis
- Current treatments for seborrheic dermatitis are not very effective or safe, prompting the need for new options.
- A clinical trial tested the safety and effectiveness of roflumilast foam, 0.3%, on adults with seborrheic dermatitis across 24 locations in the US and Canada.
- In the trial, 73.8% of patients using roflumilast foam achieved significant improvement in their condition after 8 weeks, compared to those using a placebo.
Background/objectives: Topical clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.
View Article and Find Full Text PDFBackground: Excessive sebum production is a factor in acne development. Tazarotene 0.045% lotion has demonstrated reductions in acne lesions and acne-induced sequelae.
View Article and Find Full Text PDFEffect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial.
Am J Clin Dermatol
March 2023
Background: Itch is the most bothersome symptom reported by patients with psoriasis. Safe and effective treatments for psoriasis that also address itch are needed.
Objectives: To report effects of roflumilast cream on itch-related outcomes from a Phase 2b trial.
Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis.
Objective: To evaluate the efficacy of roflumilast cream, 0.
Background: Acne prevalence may be higher in overweight/obese individuals, potentially due to hormonal, inflammatory, and/or dietary factors. However, the effects of body mass index (BMI) on topical acne treatments are largely unknown.
Methods: Post hoc analyses of changes in inflammatory/noninflammatory lesions and treatment success were conducted using phase 3 data: clindamycin phosphate/benzoyl peroxide (CP/BPO) 1.
Background: A three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance.
Objectives: We aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.
Background: Topical agents for actinic keratosis (AK), along with cryotherapy and phototherapy, are the most commonly used therapies for areas of skin with multiple AKs. Multiple options for the topical treatment of AK exist; newer therapies aim to balance efficacy with an acceptable safety and tolerability profile for the patient.
Objective: To describe the safety and tolerability of FDA-approved topical agents for the treatment of AK.
Background: Topical retinoids are recommended for acne treatment, but their use may be limited by irritation or dermatitis. Herein is an overview of the dermal sensitization, safety, tolerability, and participant satisfaction data from phase-1, -2, and -3 studies of lower-dose tazarotene 0.045% polymeric emulsion lotion.
View Article and Find Full Text PDFThe Psoriasis Area and Severity Index (PASI) is the most widely used clinical measure in clinical trials to assess disease severity of plaque psoriasis. However, the PASI is not a precise measure of severity with less precision when the regional area of involvement is < 10% of the BSA of a specific anatomical region. Degradation of precision results from the area score defaulting to '1' when the area of involvement within an anatomical region falls between 0% and 10% of the BSA for a given anatomical region.
View Article and Find Full Text PDFSince its approval in 1982, oral isotretinoin has revolutionized acne therapy. However, oral isotretinoin use has long been associated with challenges of variable bioavailability and food dependence. It is recommended to ingest oral isotretinoin with a high-fat meal in order to maximize absorption, but many patients fail to adhere to this recommendation.
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