Cysteamine Compared to Hydroquinone in Melasma

NCT ID: NCT05969587

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2020-11-11

Brief Summary

Melasma is an acquired pigmentary disorder of symmetrical hyperpigmentation appearing as variable darkness macules and patches over the forehead, cheeks, and chin, even sun-exposed areas of the body. Melasma is predominantly affects women but men can also be affected. Melasma is commonly seen in Asia, where patients with Fitzpatrick skin types III and IV, and areas of high ultraviolet radiation. It is challenging and difficult to treat melasma for its refractory and recurrent nature. There is a variety of therapeutic approaches include topical medication with Kligman's formula, oral medication, chemical peels, lasers, and light therapy.

Cysteamine (b-mercaptoethylamine) hydrochloride is the stable amino-thiol that acts as an antioxidant. It can be naturally produced in the human body and is a degrada-tion product of the amino acid L-cysteine. It has been known to be a potent depigmenting agent for about five decades. The mechanism of cysteamine for depimentation is not through melanotoxicity, which is the major depigmentation mechanism of hydro-quinone. Exogenous ochronsis is the major concern about the long-term use of hydro-quinone. Cysteamine is a thiolic compound that inhibit tyrosinase and peroxidase activity of melanocytes and produce notably greater amounts of pheomelanin but less eumelanin. In addition, thiols can act as a chelating agent of iron and copper ions Fenton reaction during pigment synthesis. Thols can also scavenge dopaquinone and deplete dopaquinone from the melanogenesis pathway. Then, higher levels of intra-cellular glutathione augmented by cysteamine cause the melanogenesis to proceed at a slower rate by shifting eumelanogenesis to pheomelanin synthesis.

Since new technology permits reduction of the sulfur-odour of cysteamine hydro-chloride, cysteamine 5% cream permit the use in topical depigmenting preparations. Considerable efficacy and safety of cysteamine 5% cream in the treatment of epidermal melasma were confirmed by comprehensive measurements in previous well-controlled studies.

However, the depigmenting efficacy of cysteamine compared with hydroquinone has never been evaluated. In addition, durability of the depigmenting efficacy has never been reported and the maintenance usage the cysteamine 5% cream has never yet been studied. In the present study, the investigators evaluate the efficacy of cysteamine 5% cream with hy-droquinone 4% cream in treating melasma and provide the maintenance regimen of cys-teamine 5% cream for Asian patients with melasma.

Conditions

Melasma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients treated with 5% cysteamine cream

Group Type: EXPERIMENTAL

5% cysteamine cream

Intervention Type: COMBINATION_PRODUCT

5% cysteamine cream (Cyspera®) was acquired from Scientis APAC Pte. Ltd. (Singapore, Singapore).Subjects were instructed to thinly apply the designated creams to their whole face every evening 15 minutes after cleansing their faces with a designated soap and the application of a skin moisturizer. The cysteamine cream was washed off 15 minutes after application

patients treated with a combination of 4% hydroquinone cream and 0.06% betamethasone valerate

Group Type: ACTIVE_COMPARATOR

hydroquinone cream group

Intervention Type: COMBINATION_PRODUCT

4% w/w hydroquinone cream (Melquine™) and 0.06% w/w betamethasone valerate cream (Rinderon®-V; equivalent to 0.05% betamethasone) were acquired from Sinphar Pharmaceutical Co., Ltd. (Yilan, Taiwan). Subjects were instructed to thinly apply the designated creams to their whole face every evening 15 minutes after cleansing their faces with a designated soap and the application of a skin moisturizer. Subjects in the hydroquinone cream group were told to apply a 2:1 ratio of the hydroquinone and betamethasone creams. The hydroquinone/betamethasone creams were left on the skin until the following morning.

Interventions

5% cysteamine cream

5% cysteamine cream (Cyspera®) was acquired from Scientis APAC Pte. Ltd. (Singapore, Singapore).Subjects were instructed to thinly apply the designated creams to their whole face every evening 15 minutes after cleansing their faces with a designated soap and the application of a skin moisturizer. The cysteamine cream was washed off 15 minutes after application

Intervention Type: COMBINATION_PRODUCT

hydroquinone cream group

4% w/w hydroquinone cream (Melquine™) and 0.06% w/w betamethasone valerate cream (Rinderon®-V; equivalent to 0.05% betamethasone) were acquired from Sinphar Pharmaceutical Co., Ltd. (Yilan, Taiwan). Subjects were instructed to thinly apply the designated creams to their whole face every evening 15 minutes after cleansing their faces with a designated soap and the application of a skin moisturizer. Subjects in the hydroquinone cream group were told to apply a 2:1 ratio of the hydroquinone and betamethasone creams. The hydroquinone/betamethasone creams were left on the skin until the following morning.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• a history of epidermal type melasma as diagnosed by a board-certified dermatologist
• above the age of 20 years
• Fitzpatrick skin type II-V

Exclusion Criteria

• pregnant
• breastfeeding
• currently receiving oral contraceptive pill or hormonal therapy
• have received topical hydroquinone, retinoid, tranexamic acid, or steroid treatment within the past month
• have received laser therapy or any other phototherapy within the past three months
• a history of allergic reactions to hydroquinone or cysteamine
• other pigmentary disorders of the face
• systemic diseases that may affect pigmentation of the face (such as systemic lupus erythematosus, jaundice, end-stage renal disease)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH108-REC1-145

Identifier Type: -

Identifier Source: org_study_id