A Seven-week, Open-label Trial Evaluating the Safety and Efficacy of a Photopneumatic Device for Mitigating Mild-to-Moderate Acne in Healthy Adolescents and Young Adults.

Objective: Photopneumatic devices combine gentle vacuum with pulsed broadband light to treat acne. This seven-week, open-label, single-group study evaluated the efficacy and safety of a photopneumatic device as acne monotherapy.

Methods: Male and female subjects between the ages of 12 and 40 years with any Fitzpatrick Skin Phototype were enrolled (N=30). Subjects had facial acne and a baseline Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate), with ≥10 to ≤50 inflammatory lesions, ≥10 but ≤100 non-inflammatory lesions, and ≤1 facial nodule. The primary efficacy endpoints were change in baseline lesion counts and the percentage of subjects achieving a ≥1-grade reduction IGA Score at Day 49. Secondary efficacy endpoints included changes in Acne Quality of Life, self-assessment, and satisfaction scores. Adverse events and tolerability were assessed.

Results: Inflammatory and non-inflammatory lesion counts significantly decreased at all time points versus baseline (for each, p<0.001); IGA scores were improved from baseline at most timepoints and 66.7 percent (20/30) achieved ≥1-grade IGA reduction at Day 49 (p<0.001). Consistent improvements in Acne Self-assessment, Acne-specific Quality of Life, and Treatment Satisfaction Questionnaires were reported. All subjects had favorable investigator and subject tolerability assessments.

Limitations: This study was limited by its small sample size and open-label study design.

Conclusion: Photopneumatic monotherapy significantly reduced acne lesions and resulted in clearer skin in all Fitzpatrick skin types. Adverse events were minor and subject satisfaction was favorable. Customizable energy and vacuum device settings makes the photopneumatic therapy device unique, allowing for a tailored individual approach to treating mild-to-moderate acne.

Clinical trial idenifier number: NCT06043102 (clinicaltrials.gov).