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Treatment of Patients With Periorbital Hyperpigmentation

Primary Purpose

Periorbital Hypermelanosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
carboxy therapy
Dermapen with topical glutathione
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periorbital Hypermelanosis focused on measuring Periorbital hypermelanosis, Carboxy therapy, Microneedling, Topical Glutathione

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Faculty of Medicine, Sohag University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rt Eye

Lt Eye

Arm 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.

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).

Outcomes

Primary Outcome Measures

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%)
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.
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 4, 2020
Last Updated
October 21, 2020
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04389788
Brief Title
Treatment of Patients With Periorbital Hyperpigmentation
Official Title
Efficacy and Safety of Combined Microneedling With Topical Glutathione Versus Carboxy Therapy in Treatment of Patients With Periorbital Hyperpigmentation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
October 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periorbital Hypermelanosis
Keywords
Periorbital hypermelanosis, Carboxy therapy, Microneedling, Topical Glutathione

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
ParticipantOutcomes Assessor
Masking Description
Both patients and the outcome assessors were blinded to the type of treatment which was done in each eye
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rt Eye
Arm Type
Active Comparator
Arm 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.
Arm Title
Lt Eye
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
carboxy therapy
Intervention Description
6 sessions of carboxy therapy every 2 weeks
Intervention Type
Device
Intervention Name(s)
Dermapen with topical glutathione
Intervention Description
6 sessions of Dermapen microneedling with topical glutathione every 2 weeks
Primary Outcome Measure Information:
Title
Change of periorbital hyperpigmentation through photo evaluation
Description
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%)
Time Frame
Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Title
Change of periorbital hyperpigmentation through dermoscopy evaluation
Description
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.
Time Frame
Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Title
Change of the patient satisfaction evaluation: scale
Description
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
Time Frame
Baseline and 1 month after end of treatment
Title
Change of periorbital hyperpigmentation into another skin problem through safety evaluation
Description
Safety evaluation to detect precentage of side effects reported either by the patient or by the physician.
Time Frame
Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Secondary Outcome Measure Information:
Title
The Dermatology Life Quality Index questionnaire
Description
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.
Time Frame
Baseline, before 3rd session, before 5th session,

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Medicine, Sohag University
City
Sohag
ZIP/Postal Code
82524
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
At the end of study july 2020.

Learn more about this trial

Treatment of Patients With Periorbital Hyperpigmentation

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