Treatment of Patients With Periorbital Hyperpigmentation

Periorbital Hypermelanosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389788
• Other study ID #: Sohagu309
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: October 21, 2020

Study information

• Verified date: October 2020
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 21, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperpigmentation
• Periorbital Hypermelanosis

Intervention

Device:
• carboxy therapy
6 sessions of carboxy therapy every 2 weeks
• Dermapen with topical glutathione
6 sessions of Dermapen microneedling with topical glutathione every 2 weeks

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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,