Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperpigmentation; Postinflammatory

Intervention / Treatment
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* Drug: Topical Cysteamine
* Drug: Topical Vehicle Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial, Double masked, double-blinded
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 participants with topical cysteamine cream<br>Participants with post-inflammatory hyperpigmentation will apply topical cysteamine cream for a 16 weeks period. | Drug: Topical Cysteamine<br>* Topical cysteamine cream applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream.<br>* Other names: Cyspera;|
| Sham Comparator: 20 participants with topical vehicle control cream<br>Participants with post-inflammatory hyperpigmentation will apply topical vehicle-control cream for a 16 weeks period. | Drug: Topical Vehicle Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pigmentation at 4 Weeks | Patients will have their lesion pigmentation scored with the hyperpigmentation index after 4 weeks | 4 weeks | 
| Change from Baseline Pigmentation at 8 Weeks | Patients will have their lesion pigmentation scored with the hyperpigmentation index after 8 weeks | 8 weeks | 
| Change from Baseline Pigmentation at 12 Weeks | Patients will have their lesion pigmentation scored with the hyperpigmentation index after 12 weeks | 12 weeks | 
| Change from Baseline Pigmentation at 16 Weeks | Patients will have their lesion pigmentation scored with the hyperpigmentation index after 16 weeks | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cysteamine, Postinflammatory Hyperpigmentation, Randomized control trial, Double blinded