Effect of NFX-179 MEK inhibitor on cutaneous neurofibromas in persons with neurofibromatosis type 1.

This phase 2a trial investigated the efficacy of NFX-179 Topical Gel, a metabolically labile MEK inhibitor, in the treatment of cutaneous neurofibromas (cNFs) in neurofibromatosis type 1. Forty-eight participants were randomized to four treatment arms: NFX-179 Topical Gel 0.05%, 0.

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.

A novel, fixed-dose calcipotriol and betamethasone dipropionate cream for the topical treatment of plaque psoriasis: Direct and indirect evidence from phase 3 trials discussed at the 30 EADV Congress 2021.

Four posters about the novel, fixed-dose calcipotriol and betamethasone dipropionate cream (CAL/BDP cream) based on Poly-Aphron Dispersion (PAD) Technology were presented at the 30 European Academy of Dermatology and Venereology (EADV) Congress 2021 and are summarized here. CAL/BDP cream was compared in two randomized, phase 3 trials to vehicle and active comparator (CAL/BDP gel/topical suspension [TS]) in adults with plaque psoriasis (NCT03802344 and NCT03308799). Pooled data from both trials demonstrated significant greater efficacy in favour of CAL/BDP cream for all efficacy endpoints, including PGA treatment success, mPASI, and mPASI75 compared to CAL/BDP gel/TS.

The Use of a Novel Artificial Intelligence Platform for the Evaluation of Rhytids.

Background: Artificial intelligence (AI) platforms are increasingly being utilized in various healthcare applications. There are few platforms that provide quantifiable assessments of dermatologic or aesthetic conditions by employing industry established scales.

Objectives: The authors sought to report the results of a pilot study that evaluated the utilization and functionality of an AI engine to measure and monitor rhytids (fine lines).

Clinical translation of choline and geranic acid deep eutectic solvent.

Choline geranate deep eutectic solvent/ionic liquid (CAGE) has shown several desirable therapeutic properties including antimicrobial activity and ability to deliver drugs transdermally in research laboratories. Here, we describe the first report of clinical translation of CAGE from the lab into the clinic for the treatment of rosacea, a common chronic inflammatory skin disorder that affects the face. We describe the seven steps of clinical translation including (a) scale-up, (b) characterization, (c) stability analysis, (d) mechanism of action, (e) dose determination, (f) GLP toxicity study, and (g) human clinical study.

A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream.

Background: The fixed dose combination of calcipotriene and betamethasone dipropionate (CAL/BDP) is a well-established, efficacious, and safe topical treatment of psoriasis.

Method: A Phase 3, multicenter, randomized, investigator-blind, active, and vehicle-controlled trial enrolling 796 patients with moderate to severe psoriasis according to the Physician Global Assessment (PGA) scale. Products were applied once daily for 8 weeks.

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study.

Background: DaxibotulinumtoxinA for Injection (DAXI) is botulinum toxin Type A formulated with a novel peptide excipient. Two pivotal, single-treatment, placebo-controlled trials demonstrated efficacy and safety for moderate or severe glabellar lines.

Objective: To further evaluate DAXI in a large, open-label, repeat-treatment study.

Open-label Extension Study Evaluating Long-term Safety and Efficacy of FMX101 4% Minocycline Foam for Moderate-to-Severe Acne Vulgaris.

This study sought to evaluate the long-term safety and efficacy of FMX101 4% topical minocycline foam for the treatment of moderate-to-severe acne. This was an open-label extension of two double-blind studies, Study 04 and Study 05. Subjects were enrolled at 35 sites in the United States and one site in the Dominican Republic.

Safety and Efficacy of EB-001, a Novel Type E Botulinum Toxin, in Subjects with Glabellar Frown Lines: Results of a Phase 2, Randomized, Placebo-Controlled, Ascending-Dose Study.

Background: Botulinum neurotoxins, which are widely used commercially for therapeutic and cosmetic applications, have historically belonged to serotypes A and B. Serotype E has a distinct profile with a faster onset and shorter duration of effect. EB-001 is a proprietary formulation of serotype E in development for aesthetic (cosmetic) and therapeutic uses.

Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials.

Background: Side effects may limit the use of current tetracycline-class antibiotics for acne.

Objective: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne.

Methods: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.

The Potential Role of Botulinum Toxin in Improving Superficial Cutaneous Scarring: A Review.

Botulinum toxins have been utilized in a number of cosmetic and therapeutic applications. One of the more novel uses of botulinum toxin involves its use to mitigate the effects of superficial cutaneous scarring. This is accomplished by decreasing the dynamic tension of a wound by denervating the underlying muscle.

A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies.

Background: FMX101 4% is a topical minocycline foam for the treatment of moderate-to-severe acne.

Objective: Evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe acne vulgaris.

Methods: Two identical phase 3 studies were conducted.

Clinically Relevant Reduction in Persistent Facial Erythema of Rosacea on the First Day of Treatment With Oxymetazoline Cream 1.0.

Background: Persistent facial erythema is a clinically challenging feature of rosacea.

Objective: To evaluate persistent erythema reduction on the first day of treatment from pooled data from two pivotal trials of topical oxymetazoline cream 1.0% (oxymetazoline) in persistent facial erythema of rosacea.

Efficacy and Safety of Naftifine HCl Cream 2% in the Treatment of Pediatric Subjects With Tinea Corporis.

Background: Tinea corporis is fungal infection of body surfaces other than the feet, groin, scalp, or beard. Naftifine hydrochloride is a topical antifungal of the allylamine class used to treat tinea corporis, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects.


Objective: To evaluate the efficacy and safety of two-weeks once daily application of naftifine cream 2% in the treatment of tinea corporis among pediatric subjects.

Clindamycin phosphate 1.2%-benzoyl peroxide (5% or 2.5%) plus tazarotene cream 0.1% for the treatment of acne.

Acne is a multifactorial chronic dermatosis that can be effectively treated with adjuvant medications. The objective of our study was to compare the tolerability and efficacy of 2 adjuvant therapies combining clindamycin phosphate 1.2%-benzoyl peroxide 5% (CLNP-BPO5) or clindamycin phosphate 1.

Clinical evidence for the role of a topical anti-inflammatory agent in comedonal acne: findings from a randomized study of dapsone gel 5% in combination with tazarotene cream 0.1% in patients with acne vulgaris.

Background: Acne pathogenesis is multifactorial and includes inflammation. Combining drugs targeting multiple components of acne pathogenesis is standard practice.

Objective: To assess the safety and efficacy of dapsone gel 5%, an anti-inflammatory agent, in combination with tazarotene cream 0.

Evaluation of self-treatment of mild-to-moderate facial acne with a blue light treatment system.

Introduction: This study evaluated the efficacy and tolerability of treating mild-to-moderate facial acne using a new, hand-held, light-emitting diode blue light device in conjunction with a foam cleanser containing 5% glycolic acid and 2% salicylic acid plus a skin rebuilding serum containing 1.25% salicylic acid, 0.5% niacinamide, 0.

Randomized comparison of the safety and efficacy of tazarotene 0.1% cream and adapalene 0.3% gel in the treatment of patients with at least moderate facial acne vulgaris.

This 16-week study evaluated once-daily tazarotene 0.1% cream and adapalene 0.3% gel in patients with moderate-to-severe acne.

Comparing a novel solubilized benzoyl peroxide gel with benzoyl peroxide/clindamycin: final data from a multicenter, investigator-blind, randomized study.

Introduction: A solubilized 5% BPO gel has been developed to enhance the bioavailability, follicular penetration, and efficacy of BPO.

Methods: Sixty-five patients with moderate facial acne vulgaris were randomly assigned to apply solubilized 5% BPO gel to one facial side and 5% BPO/1% clindamycin to the contralateral side, twice daily for four or 12 weeks.

Results: The solubilized BPO gel resulted in significantly greater reductions in non-inflammatory lesion count than BPO/clindamycin at weeks 1, 2, 3, 4 and 12 and comparable reductions in inflammatory lesion count at all time points.

Comparison of 2 clindamycin 1%-benzoyl peroxide 5% topical gels used once daily in the management of acne vulgaris.

Combination therapy for the topical treatment of acne vulgaris using benzoyl peroxide (BPO) and an antibiotic is more efficacious and better tolerated than treatment with either component alone. Moreover, the addition of BPO to antibiotic therapy is recommended as a means of preventing the development of Propionibacterium acnes antibiotic resistance. However, BPO is an irritant, and the dryness and irritation experienced by some patients using topical therapy containing BPO can negatively impact compliance.

The effect of vehicle formulation on acne medication tolerability.

Combination acne medications provide enhanced treatment opportunities. A commonly used acne therapy may combine a topical antibiotic with benzoyl peroxide (BPO) to prevent antibiotic resistance while optimizing control of microcomedone formation with a retinoid. Unfortunately, this combination of highly efficacious medications may cause irritation because of the inherent skin irritancy of BPO and retinoids.

Solubilized benzoyl peroxide versus benzoyl peroxide/clindamycin in the treatment of moderate acne.

Background: Benzoyl peroxide (BPO) is poorly soluble. A solubilized formulation of BPO has been developed to maximize its bioavailability and enhance follicular penetration.

Methods: Patients with acne vulgaris were randomly assigned to receive solubilized BPO 5% gel on one side of the face and a BPO 5%/clindamycin 1% combination product on the contralateral side, twice daily for 4 weeks.