Treatment of Patients With Periorbital Hyperpigmentation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Combined Microneedling With Topical Glutathione Versus Carboxy Therapy in Treatment of Patients With Periorbital Hyperpigmentation

Conditions
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Periorbital Hypermelanosis

Intervention / Treatment
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* Device: carboxy therapy
* Device: Dermapen with topical glutathione


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with periorbital hyperpigmentation will be treated using Carboxy theraby method at right side of face followed by microneedling using dermapen will be at left side of face.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rt Eye<br>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. | Device: carboxy therapy<br>* 6 sessions of carboxy therapy every 2 weeks<br>|
| Active Comparator: Lt Eye<br>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). | Device: Dermapen with topical glutathione<br>* 6 sessions of Dermapen microneedling with topical glutathione every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of periorbital hyperpigmentation through photo evaluation | High-resolution photographs of both sides of the face were taken. Using a physician visual analog scoring system, 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows 1 (worse), 2 (no change), 3 (<30%), 4 (30-60%), and 5 (>60%) | 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 | Dermoscopic evaluation was done using dermalite connection kit for Samsung galaxy. 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows Vasculature improvement (No 0, Yes 1) & percent of improvement. Pigmentation improvement (No 0, Yes 1) & percent of improvement. Skin improvement like atrophy and exaggerated skin markings (No 0, Yes 1) & percent of improvement. | 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 | The patients were asked to evaluate their own level of satisfaction after they completed the study on a 1-3 scale: 1 = slightly satisfied, 2 = moderately satisfied, and 3 = well satisfied | Baseline and 1 month after end of treatment | 
| Change of periorbital hyperpigmentation into another skin problem through safety evaluation | Safety evaluation to detect precentage of side effects reported either by the patient or by the physician. | Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Dermatology Life Quality Index questionnaire | The Dermatology Life Quality Index questionnaire (DLQI) is 10 questions were asked to the patients and score is 0-3 for each question. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | Baseline, before 3rd session, before 5th session, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periorbital hypermelanosis, Carboxy therapy, Microneedling, Topical Glutathione