NAC-GED 5% gel promising treatment option for moderate to severe acne

Preliminary in vitro and in vivo studies have shown that the peroxisome proliferator-activated receptor-γ modulator N-acetyl-GED-0507-34-LEVO (NAC-GED) for the treatment of acne-stimulating sebaceous cell differentiation. Effectiveness of. It improves sebum composition and controls the inflammatory process.

A group of researchers conducted a study to evaluate the efficacy and safety of NAC-GED (5% and 2%) in patients with moderate to severe facial crusts Vulgaris.

This double-blind phase II randomized controlled trial was conducted at 36 sites in Germany, Italy, and Poland. Patients aged 12-30 years with facial acne, Investigator Global Assessment (IGA) score 3-4, inflammatory and non-inflammatory lesions 20-100 years (2% or 5%) were randomly assigned to topical application of study drug or placebo. . vehicle), once a day for 12 weeks. Primary efficacy endpoints were rate of change in total disease count (TLC) from baseline and the 12-week IGA success rate. Safety endpoints were adverse events (AEs) and serious AEs.

The results of the survey are as follows.

• Between Q1 2019 and Q1 2020, 450 patients had NAC-GED 5% (n = 150), NAC-GED 2% (n = 150), or vehicle (n =). Randomly assigned. up to 150).

• The rate of change in TLC reduction was statistically significantly higher in both the NAC-GED 5% and NAC-GED 2% groups compared to vehicles.

• A greater percentage of patients treated with NAC-GED 5% experienced IGA success compared to the vehicle group.

• The success rate of IGA in the 2% NAC-GED group was 33%.

• The proportion of patients with one or more AEs in the NAC-GED group was 5%, NAC-GED 2% and vehicles were 19%, 16% and 19%, respectively.

Therefore, topical application of NAC-GED 5% reduced TLC, increased the success rate of IGA, and could be safely used in patients with scaly plaques. Therefore, the new PPARγ modulator, NAC-GED, showed an effective clinical response.

Reference:

Picardo, M., Cardinali, C., La Placa, M., Lewartowska-Białek, A., Lora, V., Micali, G., Montisci, R., Morbelli, L., Nova, A., Parodi, A., Reich, A., Sebastian, M., Turek-Urasińska, K., Weirich, O., Zdybski, J., Zouboulis, C.C. and (2022), Efficacy and safety of N-acetyl-GED-0507-34-LEVO gel in patients with moderate-to-severe facial acne vulgaris: a phase IIb randomized double-blind, vehicle-controlled trial. Br J Dermatol. https://doi.org/10.1111/bjd.21663

Keywords:

Mauro Picardo, Carla Cardinali, Michelangelo La Placa, Anita Lewartowska-Białek, Viviana Lora, Giuseppe Micali, Roberta Montisci, Luca Morbelli, Andrea Nova, Aurora Parodi, Adam Reich, Michael Sebastian, Katarzyna Turek-Urasińska, Oliver Weirich, Jacek Zdybski, Christos C. Zouboulis, the GEDACNE Study Group, Efficacy, safety, N-acetyl-GED-0507-34, LEVO, gel, patients, moderate-to severe, facial, acne, vulgaris, phase IIb, randomized, double-blind, vehicle-controlled trial, British Journal of Dermatology