Clinical trial NCT04389788: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Hypermelanosis
Keywords: Periorbital hypermelanosis
Carboxy therapy
Microneedling
Topical Glutathione
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of periorbital hyperpigmentation through photo evaluation
timeFrame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
measure: Change of periorbital hyperpigmentation through dermoscopy evaluation
timeFrame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
measure: Change of the patient satisfaction evaluation: scale
timeFrame: Baseline and 1 month after end of treatment
measure: Change of periorbital hyperpigmentation into another skin problem through safety evaluation
timeFrame: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Secondary outcomes:
measure: The Dermatology Life Quality Index questionnaire
timeFrame: Baseline, before 3rd session, before 5th session,
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
References: