Title : Nitric oxide-releasing topical gel for the management of moderate-to-severe Acne vulgaris: A meta-analysis
Abstract:
Introduction: Acne vulgaris, a common inflammatory skin disorder, poses physical and psychological challenges for millions worldwide.
Objective: This systematic review and meta-analysis investigate the promise of a nitric oxide-releasing topical gel as a potential acne treatment.
Materials and Methods: This systematic review and meta-analysis will assess the efficacy and safety of a nitric oxide-releasing (NO) topical gel 4% in treating adult acne vulgaris. Randomized Controlled Trials (RCTs) comparing NO gel to vehicle gel will be included. Outcomes of interest include inflammatory and non-inflammatory lesion counts, Investigator's Global Assessment (IGA) score, and adverse events (Application site-related). Mean difference (MD) will be used to pool continuous outcomes, while Risk Ratio (RR) will be used to pool dichotomous outcomes. Random-effects meta-analyses will be performed for quantitative synthesis. The risk of bias assessment will be conducted using the Revised Cochrane risk of bias tool for randomized trials. The certainty of the evidence will be assessed using the GRADE approach.
Results: Three studies were included in our meta-analysis. NO gel showed a significant reduction in inflammatory (MD=-1.72, 95% CI [-2.65, -0.79], P=0.0003, I2=18%) and non-inflammatory (MD=-2.64, 95% CI [-3.83, -1.44], P<0.0001, I2=0%) lesion count but caused no difference in the number of patients with improved IGA (RR=1.18, 95% CI [0.90, 1.55], P=0.24, I2=39%) at 12 weeks. Safety-wise, NO caused a superior incidence of pain (RR=4.78, 95% CI [2.12, 10.79], P=0.0002, I2=0%) while it showed a similar effect to placebo with regards to dryness (RR=2.63, 95% CI [0.73, 9.46], P=0.14, I2=0%) and erythema (RR=4.07, 95% CI [1.03, 16.03], P=0.05, I2=35%).
Conclusion: In brief, the 4% nitric oxide-releasing topical gel effectively reduces acne lesions in adults with acne vulgaris, displaying promise despite limited IGA improvement. Safety analysis indicates a modestly increased pain incidence, with dryness and erythema similar to placebo, implying an overall favorable safety profile, necessitating further comprehensive research for confirmation.
