Background: The quality of outcome assessment in acne studies has been either subjective/insufficient or time consuming through the ordinary lesion counting.
Objective: To evaluate the application of multimodal clinical imaging (MCI), a combination of imaging technology and computation, in the assessment of acne lesions in a clinical study setting.
Methods: A prospective, monocentric, single-group open study designed to evaluate the efficacy and tolerance of a cosmetic product (IP/SG) in subjects with mild-to-moderate facial acne by classical clinical counting (CCC) - change in the total/inflammatory/noninflammatory acne lesion number compared with baseline (D0) - Investigator Global Assessment (IGA) and self-reported outcomes. Concomitantly, MCI was administered. The study was performed for 12 weeks (D84) with a 4-week follow-up (D112).
Results: Mean age of patients (n = 49) was 18.2 ± 3.7 years (range 13-25). The mean acne duration was 3.8 ± 2.8 years. The total number of lesions did not differ significantly between D0/D84 by both CCC and MCI. However, the Cardiff Acne Disability Index (CADI) and uncomfortable feeling improved at D28/D0, the perception of oily skin improved at D14/D0, and the perception of sticky skin improved from D28/D0 to D56/D0. Deterioration was detected between D84/D0 and D112/D0, namely after product discontinuation. Interestingly, a change in trend was recorded for acne lesions at D14/D0 by MCI but not by CCC.
Conclusion: MCI, applied for the first time in a small clinical study setting, is at least as reliable as CCC and may allow for a sensitive longitudinal evaluation of single acne lesions and their response to products, especially in conditions where clinical evaluation reaches its limits.
Keywords: Acne; Clinical trial; Cosmetics; Dermatology life quality index; Digital imaging; Outcome; Quality of life; Skin inflammation.
© 2019 S. Karger AG, Basel.