Treatment of Patients With Periorbital Hyperpigmentation

Sohag University

Status: Completed

Conditions: Periorbital Hypermelanosis

Treatments: Device: carboxy therapy; Device: Dermapen with topical glutathione

Study type: Interventional

Funder types: Other

Identifiers

NCT04389788

Sohagu309

Details and patient eligibility

About

Periorbital hyperpigmentation (POH) is a common condition in dermatology practice. Periorbital hyperpigmentation is defined as bilateral, round, homogeneous pigmented macules.The etiology of POH is multifactorial including genetic and enviromental factors. Many treatment options are avaiblabe with variable efficacy and safety in different patients. Therefore, the investigator's study aims to evaluate the efficacy and safety of combined microneedling with topical Glutathione versus Carboxy Therapy in treatment of patients with periorbital hyperpigmentation.

Full description

Periorbital hyperpigmentation (POH) is a common skin condition which has a great negative effect on the patient quality of life. Many factors contribute in the pathogensis of POH which lead to developement of several treatment options with no treatment option has a great sucess in improving the POH and patient quality of life. Our current study tries to explore the efficacy and safety between 2 treatment methods in a split face study.

Microneedling is a process of making small punctres into the skin through small needles by device which is called a Dermapen. This microneedling method is beleived to be associated with improving the skin quality through increased collagen. This microneedling will be followed by topical application of glutathione which is a commong antioxidant with whitening effects.

Carboxy therapy is a new emerging treatment option in many dermatological diseases. It will be used in POH patients as it will be able to increase blood flow in periorbital area and improve the skin qulaity.

Enrollment: 31 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Periorbital hyperpigmentation

Exclusion criteria

• Pregnancy and lactation .
• Allergy, hypersensitivity to the formulations to be used in the study.
• Any other cutaneous or systemic disease.
• Patient who had taken any other treatment (laser, dermabrasion) on the affected region performed less than 6 months prior to the beginning of the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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31 participants in 2 patient groups

Rt Eye

Active Comparator group

Description:

The right eye of the patients received carboxy therapy for 6 sessions every 2 weeks. The used device is locally manufactured by a national company for esthetic and dermatological devices. Carbon dioxide gas was subcutaneously injected at the lateral one-third of each eye lid (5 cc gas in each puff according to standardized flowmetry) using insulin syringe. Compression of the injected area will be avoided to prevent rapid leakage of the gas.

Treatment:

Device: carboxy therapy

Lt Eye

Active Comparator group

Description:

The left eye of the same patients received microneedling with topical glutathione for 6 sessions every 2 weeks. Microneedling was done with Derma pen which is automatic and rechargeable device (vibrating frequency : 6500-10000 r/m , vibration speed level 5 , model :Ultima A6 , company : Dr ,pen and country : Korea). Needle length is adjustable from 0.25 mm to 0,5 mm.Needles number : 36 .Then, Patient was subjected to topical glutathione about 0.25 ml (vial : 600mg/5ml).

Treatment:

Device: Dermapen with topical glutathione