NCT05206318

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

January 25, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

January 23, 2022

Last Update Submit

January 23, 2022

Conditions

Hyperpigmentation; Postinflammatory

Keywords

CysteaminePostinflammatory HyperpigmentationRandomized control trialDouble blinded

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

20 participants with topical cysteamine cream

EXPERIMENTAL

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

Drug: Topical Cysteamine

20 participants with topical vehicle control cream

SHAM COMPARATOR

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

Drug: Topical Vehicle Control

Interventions

Topical CysteamineDRUG

Topical cysteamine cream applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream.

Also known as: Cyspera
20 participants with topical cysteamine cream
Topical Vehicle ControlDRUG

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.

20 participants with topical vehicle control cream

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 20 years old
  • Patients with postinflammatory hyperpigmentation for more than 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

RECRUITING

Related Publications (6)

  • Ahramiyanpour N, Saki N, Akbari Z, Shamsi-Meymandi S, Amiri R, Heiran A. Efficacy of topical cysteamine hydrochloride in treating melasma: a systematic review. J Cosmet Dermatol. 2021 Nov;20(11):3593-3602. doi: 10.1111/jocd.14494. Epub 2021 Sep 30.

    PMID: 34591360RESULT

  • Nguyen J, Remyn L, Chung IY, Honigman A, Gourani-Tehrani S, Wutami I, Wong C, Paul E, Rodrigues M. Evaluation of the efficacy of cysteamine cream compared to hydroquinone in the treatment of melasma: A randomised, double-blinded trial. Australas J Dermatol. 2021 Feb;62(1):e41-e46. doi: 10.1111/ajd.13432. Epub 2020 Sep 27.

    PMID: 32981068RESULT

  • Karrabi M, David J, Sahebkar M. Clinical evaluation of efficacy, safety and tolerability of cysteamine 5% cream in comparison with modified Kligman's formula in subjects with epidermal melasma: A randomized, double-blind clinical trial study. Skin Res Technol. 2021 Jan;27(1):24-31. doi: 10.1111/srt.12901. Epub 2020 Jun 25.

    PMID: 32585079RESULT

  • Farshi S, Mansouri P, Kasraee B. Efficacy of cysteamine cream in the treatment of epidermal melasma, evaluating by Dermacatch as a new measurement method: a randomized double blind placebo controlled study. J Dermatolog Treat. 2018 Mar;29(2):182-189. doi: 10.1080/09546634.2017.1351608. Epub 2017 Jul 26.

    PMID: 28678558RESULT

  • Mansouri P, Farshi S, Hashemi Z, Kasraee B. Evaluation of the efficacy of cysteamine 5% cream in the treatment of epidermal melasma: a randomized double-blind placebo-controlled trial. Br J Dermatol. 2015 Jul;173(1):209-17. doi: 10.1111/bjd.13424. Epub 2015 May 29.

    PMID: 25251767RESULT

  • Karrabi M, Mansournia MA, Sharestanaki E, Abdollahnejad Y, Sahebkar M. Clinical evaluation of efficacy and tolerability of cysteamine 5% cream in comparison with tranexamic acid mesotherapy in subjects with melasma: a single-blind, randomized clinical trial study. Arch Dermatol Res. 2021 Sep;313(7):539-547. doi: 10.1007/s00403-020-02133-7. Epub 2020 Sep 2.

    PMID: 32879998RESULT

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Cysteamine

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MercaptoethylaminesEthylaminesAminesOrganic ChemicalsSulfhydryl CompoundsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The packaging and labeling of the topical product were the same in both group. The subjects were randomized in by an interactive web response system that provided study kit number from the randomization list at the time of inclusion into the study. The randomization list was kept strictly confidential throughout the study and was not available to the investigator and patient or any other personnel who may influence the study data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial, Double masked, double-blinded
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2022

First Posted

January 25, 2022

Study Start

December 10, 2021

Primary Completion

June 10, 2022

Study Completion

December 10, 2022

Last Updated

January 25, 2022

Record last verified: 2021-12

Locations

TW(1)