News - July 2021

The United States FDA announced that a new hyaluronic acid (HA) dermal filler is now approved for cheek augmentation and for correction of midface contour deficiencies in adults aged 21 years or older.

Approval comes after the results of a randomized, comparator-controlled, multicenter, pivotal phase 3 study into the effectiveness and safety of the HA filler. In total, 270 patients were randomized to either group A, which compared the effectiveness and safety of the HA filler vs a comparator product (n=142), or group B, which compared the HA filler as injected by needle (n=60) on one side of the face vs cannula (n=60) in the other in the same patient.

Results showed that patients who received the new HA filler required less total volume injected to achieve optimal results vs the comparator product. At least 76% of patients in group A who received the HA filler were satisfied with their results across all FACE-Q questions through week 48. In group B, 91% were satisfied with their cheeks across all FACE-Q questions through all time points through study completion.

Further, the HA filler showed similar efficacy and safety when injected with a needle vs a cannula.

In addition to cheek augmentation and midface contour deficiency correction, the HA filler and its family of products are indicated to treat moderate to severe facial wrinkles and folds and volume loss of the dorsal hand and lip augmentation.

Reference
Galderma receives FDA approval for Restylane^® contour for cheek augmentation and correction of midface contour deficiencies. Press release. Galderma; June 29, 2021. Accessed June 29, 2021. https://prnmedia.prnewswire.com/news-releases/galderma-receives-fda-approval-for-restylane-contour-for-cheek-augmentation-and-correction-of-midface-contour-deficiencies-301321891.html

Hidradenitis suppurativa (HS) is an independent risk factor for adverse pregnancy and maternal outcomes, according to a recent study published in Journal of the American Academy of Dermatology.

Researchers compared risk of adverse pregnancy and maternal outcomes among women with and without HS and evaluated the influence of comorbid conditions in a retrospective cohort analysis conducted between January 1, 2011, and September 30, 2015.

HS pregnancies had a higher risk of spontaneous abortion, preterm birth, gestational diabetes mellitus, gestational hypertension, preeclampsia, and cesarean section compared with control pregnancies. Potential influences of disease duration, activity, or severity and newborn outcomes were not evaluated.

“HS appears to be an independent risk factor for adverse pregnancy and maternal outcomes,” stated the study authors. “This risk is influenced by comorbidities that may be modifiable with early identification and management,” they added.

Reference
Fitzpatrick L, Hsiao J, Tannenbaum R, Strunk A, Garg A. Adverse pregnancy and maternal outcomes in women with hidradenitis suppurativa. J Am Acad Dermatol. Published June 11, 2021. doi:10.1016/j.jaad.2021.06.023

In adult patients with alopecia areata (AA) and at least 50% scalp hair loss, the oral Janus kinase inhibitor baricitinib is a safe and effective treatment option, according to a recent study published in Journal of the American Academy of Dermatology.

Researchers aimed to evaluate efficacy and safety of baricitinib in patients with at least 50% scalp hair loss in a phase 2 study of adults with AA. Patients were randomized to receive placebo or baricitinib 1 mg, 2 mg, or 4 mg once daily. Analyses were conducted after all patients completed weeks 12 and 36 or discontinued treatment prior to these time points. Treatment success was measured using the Severity of Alopecia Tool (SALT) score less than or equal to 20 at week 36.

In total, 110 patients were included in the study (placebo, 28 patients; baricitinib 1-mg, 28; 2-mg, 27; 4-mg, 27). Of patients who received baricitinib 2 mg, 33% (P=.016) achieved SALT score 20 or less at week 36. A total of 51.9% of patients receiving baricitinib 4 mg achieved SALT score 20 or less at week 36. Baricitinib was well tolerated and safe to use.

“These results support the efficacy and safety of baricitinib in patients with [at least] 50% scalp hair loss,” concluded the study authors. 

Reference
King B, Ko J, Forman S, et al. Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: phase 2 results from a randomized controlled study. J Am Acad Dermatol. Published online June 3, 2021. doi:10.1016/j.jaad.2021.05.050

Apple cider vinegar soaks are not an effective method to alter skin bacterial microbiome in patients with atopic dermatitis (AD), according to a recent study published in PLoS One.

“In this study, we examined the effects of topical dilute [apple cider vinegar] soaks on Staphylococcus aureus abundance, skin bacterial microbiome composition, and skin bacterial microbiome diversity in AD and healthy skin,” explained the study authors.

Researchers performed a randomized, nonblinded, single-institution, split-arm pilot study in which 11 participants with AD were enrolled. The participants soaked one arm in apple cider vinegar and the other arm in tap water for 10 minutes per day. Skin bacteria samples were collected before and after 14 days of treatment and analyzed using 16S sequencing.

After 2 weeks of daily treatments, no difference in skin microbiome composition or abundance of S aureus was noted.

“Our results suggest that daily soaks in 0.5% apple cider vinegar are not an effective method of altering the skin bacterial microbiome in [AD],” concluded the study authors.

Reference
Luu LA, Flowers RH, Gao Y, et al. Apple cider vinegar soaks do not alter the skin bacterial microbiome in atopic dermatitis. PLoS One. 2021;16(6):e0252272. doi:10.1371/journal.pone.0252272

The FDA announced approval of a new bioengineered allogeneic cellularized construct (BACC) for the treatment of deep partial-thickness thermal burns. Deep partial-thickness burns contain intact dermal elements and are clinically indicated for surgical intervention.

The approval comes after demonstrated effectiveness and safety in two randomized clinical studies involving 101 adult patients with deep partial-thickness thermal burns caused by direct contact with an external heat source such as steam, scalding water, hot surfaces, or fire. In the studies, two burn wounds of comparable area and depth after excision were identified on each patient and were randomized to receive either a single BACC application or autograft.

Overall, burn wounds that received the BACC showed comparable wound closure rates to those than received autograft application in the trials. The BACC also significantly decreased need for autografts after 3 months at BACC-treatment sites. Safety was comparable to autografting, and common side effects reported by patients included pruritus, blisters, hypertrophic scarring, and impaired healing.

The BAAC is an allogeneic produced from human keratinocytes and dermal fibroblasts, which are grown together in murine collagen-dsat to create a bilayered cellularized scaffold.

Reference
FDA approves StrataGraft for the treatment of adults with thermal burns. Press release. US Food and Drug Administration. Published June 15, 2021. Accessed June 16, 2021. https://www.prnewswire.com/news-releases/fda-approves-stratagraft-for-the-treatment-of-adults-with-thermal-burns-301313055.html

Three microRNAs (miRNAs) were identified as being overexpressed in acne lesions and clinically uninvolved skin in participants prone to scarring.

Researchers aimed to establish a miRNA signature for acne and acne-associated atrophic scarring. They also identified whether a pattern of circulating miRNA is evident in patients who are prone to scarring.

The study recruited 41 participants and quantified circulating miRNA from plasma samples in all participants. In 9 patients, whole microRNAome was undertaken from tissue specimens including lesional, normal, and scarred skin.

The miRNAs miR-223, miR-21, and miR-150 were overexpressed in acne lesions and in clinically uninvolved skin participants prone to scarring. Elevated levels of circulating miRNA-21 and miRNA-150 were found in the subgroup.

“The presence of elevated levels of these specific miRNAs in the serum of patients with acne raises the potential of a blood test to identify those at risk of scarring, allowing for earlier intervention with effective therapy,” concluded the study authors. 

Reference
Ghumra W, Lee N, Whitehouse H, Bhutani R, Lagos D, Layton AM. MicroRNAs as biomarkers of atrophic scarring in acne; a cross-sectional analysis of 41 patients. Clin Exp Dermatol. Published online June 8, 2021. doi:10.1111/ced.14792

Delayed injection site reactions to the mRNA-1273 SARS-CoV-2 vaccine (Moderna vaccine) occur commonly in women and do not lead to serious adverse events.

Researchers performed an observational cohort study of hospital workers who received the Moderna vaccine between December 14, 2020, and January 8, 2021, and the onset of an injection site reaction 48 hours or more after administration of their first or second dose, based on their reports to an employee hotline.

Thirteen female employees reported a pruritic rash at the injection site appearing 3 to 9 days after receiving their initial dose. Five employees reported milder or similar reactions with earlier onset after a second dose. One reported a delayed reaction only after the second dose. No serious adverse events were reported. The cases represented 1.1% of the female employees who received their first dose.

“These results suggest that delayed-onset, injection-site pruritic rashes after mRNA-1273 SARS-CoV2 vaccine administration, lasting up to a week, occur commonly in females, do not lead to serious sequela, and should not deter receipt of the second vaccine dose,” concluded the study authors.

Reference
Jacobson MA, Zakaria A, Maung Z, et al. Incidence and characteristics of delayed injection site reaction to the mRNA-1273 SARS-CoV2 vaccine (Moderna) in a cohort of hospital employees. Clin Infect Dis. Published June 4, 2021. doi:10.1093/cid/ciab518

Metabolic syndrome (MetS) has a higher prevalence in patients with psoriatic arthritis (PsA) compared with patients who have psoriasis and rheumatoid arthritis (RA), according to a recent study.

To determine whether there is an increased prevalence of MetS in PsA populations compared with psoriasis and RA, researchers conducted a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines and assessed the quality of the studies using the Joanna Briggs Institute Checklist for Prevalence Studies.

The pooled prevalence of MetS in PsA populations was 0.46 ± 0.06 (95% CI, 0.40-0.51) compared with 0.34 ± 0.03 (95% CI, 0.32-0.37) in psoriasis populations and 0.31 ± 0.04 (95% CI, 0.27-0.35) in RA populations.

“The prevalence of MetS is significantly increased in PsA populations compared with [psoriasis] and RA populations,” concluded the study authors. “Further studies should be performed using a standardized definition of MetS in PsA, RA, and [psoriasis] populations to determine whether addressing the metabolic components in MetS offers any therapeutic benefits and in terms of attaining MDA and improving cardiovascular health,” they added.

Reference
Loganathan A, Kamalaraj N, El-Haddad C, Pile K. Systematic review and meta-analysis on prevalence of metabolic syndrome in psoriatic arthritis, rheumatoid arthritis and psoriasis. Int J Rheum Dis. Published online June 2, 2021. doi:10.1111/1756-185X.14147