Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation

Chang Gung Medical Foundation

Status: Unknown

Conditions: Hyperpigmentation; Postinflammatory

Treatments: Drug: Topical Cysteamine; Drug: Topical Vehicle Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05206318

IRB202101456A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

20 participants with topical cysteamine cream

Experimental group

Description:

Participants with post-inflammatory hyperpigmentation will apply topical cysteamine cream for a 16 weeks period.

Treatment:

Drug: Topical Cysteamine

20 participants with topical vehicle control cream

Sham Comparator group

Description:

Participants with post-inflammatory hyperpigmentation will apply topical vehicle-control cream for a 16 weeks period.

Treatment:

Drug: Topical Vehicle Control