Treatment of Patients With Periorbital Hyperpigmentation

What Was Tested

This registered not phased trial tested Glutathione for hyperparathyroidism.

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.

It had two arms (groups): Rt Eye (active comparator) and Lt Eye (active comparator).

The registry classes the interventions as device.

More on the Plan

Periorbital hyperpigmentation (POH) is a common skin condition which has a great negative effect on the patient quality of life.

Microneedling is a process of making small punctres into the skin through small needles by device which is called a Dermapen.

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.

Who Took Part

The registry lists 31 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with Periorbital hyperpigmentation.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: pregnancy and lactation ; allergy, hypersensitivity to the formulations to be used in the study; any other cutaneous or systemic disease.

How the Study Was Run

Design: non-randomized, single-group and double-blind.

Blinding on both sides kept the hyperparathyroidism participants and researchers unaware of who received Glutathione.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2020-02-12 with completion listed for 2020-10-10.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change of periorbital hyperpigmentation through photo evaluation (time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment). Change of periorbital hyperpigmentation through dermoscopy evaluation (time frame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment). Change of the patient satisfaction evaluation: scale (time frame: Baseline and 1 month after end of treatment).

It also tracked 1 secondary outcome, for example The Dermatology Life Quality Index questionnaire.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Glutathione in 31 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, Hyperparathyroidism research.