Efficacy and Safety of Carboxytherapy versus Combined Microneedling with Topical Glutathione in the Treatment of Patients with Periorbital Hyperpigmentation: An Evaluator-Blind, Split-Face, Controlled Pilot Clinical Trial

羧基疗法与微针联合局部应用谷胱甘肽治疗眼周色素沉着患者的疗效和安全性比较:一项评估者盲法、半脸对照试点临床试验

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Abstract

BACKGROUND: Periorbital hyperpigmentation (POH) is a common skin condition that presents as infraorbital darkening. POH has a multifactorial etiology. Studies evaluating POH treatment are several with varying satisfaction results. OBJECTIVES: To compare carboxytherapy and microneedling (MN) combined with topical glutathione for POH treatment. MATERIALS AND METHODS: A split-face pilot clinical trial was conducted on 31 female patients with POH. Carboxytherapy injection was done at the right periorbital area, and MN with topical glutathione (Left periorbital area), for 6 biweekly sessions. Visual analogue scale (VAS), dermoscopic evaluation, patient satisfaction, and patient dermatology life quality index questionnaire (DLQI), safety evaluation were done with 3 months follow up. The trial registry number is NCT04389788. RESULTS: Carboxytherapy showed a higher significant improvement as regards VAS evaluation compared to MN with glutathione during the active treatment phase (P = 0.001) and during the follow-up phase (P = 0.006). Also, the dermoscopic evaluation showed a statistically significant improvement in the Carboxytherapy group. DLQI showed a statistically significant improvement (P <.001). As regards patient satisfaction, carboxytherapy showed in comparison to MN with glutathione (80.6% vs 25.8% in moderate satisfaction) and (3.2% vs 0% in marked satisfaction respectively) (P = .05). As regards the patients' safety, there was no significant difference between both eyes (P = .23). CONCLUSIONS: Carboxytherapy showed higher efficacy than MN with glutathione in POH patients. Carboxytherapy improved clinical, dermoscopic, patient satisfaction, and patient DLQI; with a good safety profile.

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