Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation

N/AUnknownNCT05206318

Chang Gung Memorial Hospital40 enrolled

Overview

Post-inflammatory hyperpigmentation is a common pigmentary skin disorder that is refractory to treatment. The treatment for postinflammatory hyperpigmentation is limited. Recent studies have shown that the topical skin care product cysteamine cream has a significant decrease in melanin index without obvious side effects in other dark spots such as melasma. The goal of this study is to determine the safety and efficacy of topical cysteamine in the treatment of post-inflammatory hyperpigmentation.

Post-inflammatory hyperpigmentation is a common pigmentary skin disorder that is refractory to treatment and troublesome for darker skin individuals. The current treatment with conventional bleaching cream may result in skin irritation and ochronosis that is irreversible. Recent studies have shown that the topical cysteamine cream is safe and effective for dark spots such as melasma and lentigo with no significant side effects. The primary aim of this study is to evaluate the safety and efficacy of topical cysteamine for postinflammatory hyperpigmentation. We conduct a randomized control, double-blinded trial to include 40 patients with postinflammatory hyperpigmentation. Clinical photography with VISIA skin imaging system,mexameter, transepidermal water loss, optical coherence tomography were used to evaluate the efficacy of treatment on a monthly basis for four months period. The patient was evaluated by two blinded investigator using the investigator global assessment. Patient global assessment was also recorded monthly.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hyperpigmentation; Postinflammatory

Interventions

Topical CysteamineDRUG

Topical cysteamine cream applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream.

Topical Vehicle ControlDRUG

Topical vehicle control cream without cysteamine active ingredients applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream.

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Over 20 years old * Patients with postinflammatory hyperpigmentation for more than 3 months. Exclusion Criteria: * Patients with topical hydroquinone, oral tranexamic acid and/or other skin whitening agents. * Patients that receive or planning to receive laser treatment for spot removal during the study period. * Individuals with allergic history to cysteamine or vehicle ingredients. * Pregnant patients or patients planning to become pregnant during the time of the study.

Locations (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline Pigmentation at 4 Weeks

Patients will have their lesion pigmentation scored with the hyperpigmentation index after 4 weeks

Time frame: 4 weeks

Change from Baseline Pigmentation at 8 Weeks

Patients will have their lesion pigmentation scored with the hyperpigmentation index after 8 weeks

Time frame: 8 weeks

Change from Baseline Pigmentation at 12 Weeks

Patients will have their lesion pigmentation scored with the hyperpigmentation index after 12 weeks

Time frame: 12 weeks

Change from Baseline Pigmentation at 16 Weeks

Patients will have their lesion pigmentation scored with the hyperpigmentation index after 16 weeks

Time frame: 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.