Taking an EYE VIEW

Evaluating the effectiveness and safety of a topical under-eye serum, Melalumin, covering clinical finds and patient satisfaction, in the treatment of periorbital hyperpigmentation, Aesthetic Medicine India – in association with Menarini Group – presents a detailed analysis.

IN ASSOCIATION WITH

Periorbital hyperpigmentation (POH), a common problem amongst Indians, is rooted in several exogenous and endogenous factors. Often referred to as dark circles, it is diagnosed as periocular hyperpigmentation, periorbital melanosis, infraorbital darkening, infraorbital discoloration, or idiopathic cutaneous hyperchromia of the orbital region. The semicircular rings around the eyes comprising pigmented macules are uniformly spread, and offer a stark distinction against the skin tone of the rest of the face. POH is known to affect a patient’s psychological set-up, and may be responsible for their low self-esteem. As per a study by Huang YL and others1, “Periorbital hyperpigmentation was classified into pigmented (brown colour), vascular (blue/pink/purple colour), structural (skin colour), and mixed type based on the clinical appearance assessed by the physician. The mixed type of dark eye circle included the following four subtypes: as pigmented-vascular (PV), pigmented-structural (PS), vascular-structural (VS), and a combination of the three.”

Diagnosis of POH majorly depends on the clinical examination, including manual stretching of the lower eyelid skin and evaluation of epidermal and dermal pigmentation. As per a report in The Journal of Clinical and Aesthetic Dermatology2, “The causative factors include genetic or heredity, excessive pigmentation, postinflammatory hyperpigmentation secondary to atopic and allergic contact dermatitis, periorbital edema, excessive vascularity, and shadowing due to skin laxity and tear trough associated with ageing.”

An open label single arm prospective study

Not much research has been done in the area of POH, especially in the context of topical application. However, Dr BS Chandrashekar and Soumya Soragavi, Department of Dermatology, CUTIS Academy of Cutaneous Sciences, have conducted an open label single arm prospective study on the effectiveness and safety of topical under-eye serum MelaluminTM in Indian patients with POH.

The study, conducted across three months, included 85 patients in the age group of <55 years of age, who are diagnosed with mildto-severe (grade I to grade IV) pigmentary POH, All the subjects were instructed to apply Melalumin® (containing aldavine 5X (1 per cent), tyrostat 09 (2 per cent) and lanachrys 2B (1 per cent)) under-eye serum twice daily for three months.

Studies found that the overall mean percentage improvement of 49.47 per cent (p<0.05). 88.24 per cent of the patients showed >25 per cent improvement while 44.71 per cent showed >50 per cent improvement.

In this study, a majority of the subjects were females (84.71 per cent) and most of the patients (89.41 per cent) were in the age group of 20-40 years.

Summary and conclusion

This open label single-arm prospective study demonstrated the safety and effectiveness of Melalumin® under-eye serum in Indian patients with pigmentary POH. In addition to clinical improvements observed by the dermatologists, patients also exhibited high satisfaction levels with the treatment outcomes. As expected, being a topical application, no safety concerns were noted.

In view of the limited number of studies exploring POH management options in Indian patients, the study provides crucial insights and lays the foundation for the conduct of randomised controlled trials to better explore effectiveness and safety outcomes in larger population groups and also to confirm findings of this study. However, the study met the required sample size, thus confirming the validity of the findings.

Thus, Melalumin® under-eye serum is safe and effective in Indian patients with pigmentary POH.