Clinical trial NCT05206318: Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation
Official title: Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation: A Randomized Control, Double Blinded-trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperpigmentation; Postinflammatory
Keywords: Cysteamine
Postinflammatory Hyperpigmentation
Randomized control trial
Double blinded
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Scientis Pharma SA
First posted: 2022-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial, Double masked, double-blinded
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Pigmentation at 4 Weeks
timeFrame: 4 weeks
measure: Change from Baseline Pigmentation at 8 Weeks
timeFrame: 8 weeks
measure: Change from Baseline Pigmentation at 12 Weeks
timeFrame: 12 weeks
measure: Change from Baseline Pigmentation at 16 Weeks
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.