Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation

Not Applicable

• Conditions: Hyperpigmentation; Postinflammatory
• Interventions: Drug: Topical Cysteamine; Drug: Topical Vehicle Control

• Registration Number: NCT05206318
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-10
• Study First Submitted: 2022-01-23
• Study First Submitted QC: 2022-01-23
• Last Update Submitted: 2022-01-23
• Study First Posted: 2022-01-25
• Last Update Posted: 2022-01-25
• Primary Completion: 2022-06-10
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 participants with topical cysteamine cream	Topical Cysteamine	Participants with post-inflammatory hyperpigmentation will apply topical cysteamine cream for a 16 weeks period.
20 participants with topical vehicle control cream	Topical Vehicle Control	Participants with post-inflammatory hyperpigmentation will apply topical vehicle-control cream for a 16 weeks period.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Pigmentation at 8 Weeks	8 weeks	Patients will have their lesion pigmentation scored with the hyperpigmentation index after 8 weeks
Change from Baseline Pigmentation at 4 Weeks	4 weeks	Patients will have their lesion pigmentation scored with the hyperpigmentation index after 4 weeks
Change from Baseline Pigmentation at 12 Weeks	12 weeks	Patients will have their lesion pigmentation scored with the hyperpigmentation index after 12 weeks
Change from Baseline Pigmentation at 16 Weeks	16 weeks	Patients will have their lesion pigmentation scored with the hyperpigmentation index after 16 weeks

Trial Locations

Locations (1)

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan