Cysteamine Compared to Hydroquinone in Melasma

NCT05969587 | Completed Phase 3

• 1 other identifier: CMUH108-REC1-145
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change of Baseline Melasma Area and Severity Index (MASI) scores

  MASI scores were computed according to the formula proposed by Kimbrough-Green et al. (1994) , whereby the surface area is graded as 0 (no involvement), 1 (\< 10% involvement), 2 (10-29% involvement), 3 (30-49% involvement), 4 (50-69% involvement), 5 (70-89% involvement), and 6 (90-100% involvement). Darkness and homogeneity were graded as 0 (absent), 1 (slight), 2 (mild), 3 (marked), and 4 (severe).

  Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.

Secondary Outcomes (3)

• Erythema, melanin content, and luminance

  Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.

• Spots, wrinkles, skin texture, pore numbers, UV spots, brown spots, red areas, and porphyrins

  Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.

• patient satisfaction on depigmentation and overall satisfaction

  The satisfaction scale was evaluated after 12 week of treatment.

Study Arms (2)

patients treated with 5% cysteamine cream

EXPERIMENTAL

Combination Product: 5% cysteamine cream

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

ACTIVE COMPARATOR

Combination Product: hydroquinone cream group

Interventions

5% cysteamine cream 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 5% cysteamine cream

hydroquinone cream group 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.

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404332, Taiwan

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 1, 2023
• Study Start: November 28, 2019
• Primary Completion: September 11, 2020
• Study Completion: November 11, 2020
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

TW (1)