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

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.

Keywords: Carboxytherapy; microneedling; periorbital hyperpigmentation; topical glutathione.

Figure 1

A CONSORT flow chart of the study

Figure 2

Comparison between the two eyes according to patient satisfaction

Figure 3

(a and b) A 26-year female patient showed grade 4 VAS improvement in POH for Rt eye and grade 2 for Lt eye through treatment phase (baseline, 3^rd session, and 6^th session) and the follow-up phase (6^th session, 1 month, and 3 months follow up); (c and d) Baseline dermoscopic (x10) evaluation showed mixed (vascular & pigmented) type POH. Rt eye showed vascular and pigmented components improvement 30, 40% respectively through the treatment phase. Lt eye showed 15% improvement for the vascular component but no improvement in the pigmented component. These changes were maintained during the follow-up phase

Figure 4

(a and b) A 27-year female patient showed grade 3 VAS improvement in POH for Rt eye and grade 2 for Lt eye through treatment phase and the follow-up phase; (c and d) Baseline dermoscopic (x10) evaluation showed mixed (vascular & pigmented) type POH. Rt eye showed vascular and pigmented components improvement 20, 30% respectively through the treatment phase. Lt eye showed 20% improvement for both vascular and pigmented components. These changes were maintained during the follow-up phase