Clinical trial NCT05969587: Cysteamine Compared to Hydroquinone in Melasma
Official title: Compare the Efficacy and Safety Profile of Cysteamine and Hydroquinone in Melasma as Topical Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melasma
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change of Baseline Melasma Area and Severity Index (MASI) scores
timeFrame: Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.
Secondary outcomes:
measure: Erythema, melanin content, and luminance
timeFrame: Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.
measure: Spots, wrinkles, skin texture, pore numbers, UV spots, brown spots, red areas, and porphyrins
timeFrame: Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.
measure: patient satisfaction on depigmentation and overall satisfaction
timeFrame: The satisfaction scale was evaluated after 12 week of treatment.
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: