NCT05206318

Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation

Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation: A Randomized Control, Double Blinded-trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperpigmentation; Postinflammatory

Interventions

Type	Name	Description
DRUG	Topical Cysteamine	Topical cysteamine cream applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream.
DRUG	Topical Vehicle Control	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.

Timeline

• Start date: 2021-12-10
• Primary completion: 2022-06-10
• Completion: 2022-12-10
• First posted: 2022-01-25
• Last updated: 2022-01-25

Locations

1 site across 1 country: Taiwan