Treatment of Patients With Periorbital Hyperpigmentation

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

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.

Study Overview

• Status: Completed
• Conditions: Periorbital Hypermelanosis
• Intervention / Treatment: Device: carboxy therapy; Device: Dermapen with topical glutathione

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Faculty of Medicine, Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rt Eye; 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; 6 sessions of carboxy therapy every 2 weeks
Active Comparator: Lt Eye; 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; 6 sessions of Dermapen microneedling with topical glutathione every 2 weeks

What is the study measuring?

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,

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 21, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Microneedling; Periorbital hypermelanosis; Carboxy therapy; Topical Glutathione
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: Sohagu309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: At the end of study july 2020.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No