Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation

January 23, 2022 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 33305
        • Recruiting
        • Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20 participants with topical cysteamine cream
Participants with post-inflammatory hyperpigmentation will apply topical cysteamine cream for a 16 weeks period.
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.
Other Names:
  • Cyspera
Sham Comparator: 20 participants with topical vehicle control cream
Participants with post-inflammatory hyperpigmentation will apply topical vehicle-control cream for a 16 weeks period.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Scientis Pharma SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Anticipated)

June 10, 2022

Study Completion (Anticipated)

December 10, 2022

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

January 23, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 23, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202101456A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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