MelasmaPhase 3NCT05969587
Cysteamine Compared to Hydroquinone in Melasma
A Phase 3 study testing 5% cysteamine cream and hydroquinone cream group in people with Melasma, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- 5% cysteamine cream and hydroquinone cream group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Nov 2019to 11 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a history of epidermal type melasma as diagnosed by a board-certified dermatologist
- above the age of 20 years
- Fitzpatrick skin type II-V
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Efficacy and Safety Profile of Cysteamine and Hydroquinone in Melasma as Topical Application
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.
Read more
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
- Being tested
- 5% cysteamine cream, hydroquinone cream group
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% cysteamine creamCombination 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
hydroquinone cream groupCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| patients treated with 5% cysteamine cream | Experimental | Not described Receives: Combination Product: 5% cysteamine cream |
| patients treated with a combination of 4% hydroquinone cream and 0.06% betamethasone valerate | Active comparator | Not described Receives: Combination Product: hydroquinone cream group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.
Secondary outcomes (3)
Erythema, melanin content, and luminance
Erythema, melanin content, and luminance at three predesignated regions of the face were measured with the skin color probe of DermaLab® Combo (Cortex Technology, Hadsund, Denmark), utilizing two high intensity white LED light sources and four 16-color sensor elements. Erythema and melanin content were measured in arbitrary units between 0 and 99.9, while luminance was derived from the CIELAB color space values whereby the lightness value is calculated from a 100% relative luminance of white and an offset near black. VISIA® Skin Analysis System (Canfield Scientific, Fairfield, New Jersey) was then used to take frontal and lateral cross-polarized photographs of the bilateral face in both the visible light and ultraviolet spectrum at fixed angles, distances, and camera settings. The measurement units used above are all arbitrary units.
Measured: 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
The standardized photographs were then evaluated for spots, wrinkles, skin texture, pore numbers, UV spots, brown spots, red areas, and porphyrins by comparing them to Canfield's worldwide skin feature database and calculating the percentile ranking for each feature, whereby a higher percentile score indicates better skin condition.
Measured: Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.
patient satisfaction on depigmentation and overall satisfaction
During follow-up, patient satisfaction on depigmentation and overall satisfaction were evaluated and scored on a scale between one to five, with one being extremely dissatisfied and five being extremely satisfied.
Measured: The satisfaction scale was evaluated after 12 week of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start28 Nov 2019
- Primary completion11 Sep 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969587
- Sponsor's protocol ID
- CMUH108-REC1-145
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Efficacy and Safety Profile of Cysteamine and Hydroquinone in Melasma as Topical Application
- ClinicalTrials.gov ID
- NCT05969587
- Acronym / sponsor ID
- CMUH108-REC1-145
- Conditions
- Melasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a history of epidermal type melasma as diagnosed by a board-certified dermatologist
- above the age of 20 years
- Fitzpatrick skin type II-V
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% cysteamine cream5% 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 | Combination product | patients treated with 5% cysteamine cream |
| hydroquinone cream group4% 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. | Combination product | patients treated with a combination of 4% hydroquinone cream and 0.06% betamethasone valerate |
Primary outcome
Change of Baseline Melasma Area and Severity Index (MASI) scores
Time frame: Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.
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).
3 secondary outcomes
Erythema, melanin content, and luminance
Time frame: 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
Time frame: Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.
patient satisfaction on depigmentation and overall satisfaction
Time frame: The satisfaction scale was evaluated after 12 week of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5% cysteamine cream and hydroquinone cream group in people with Melasma, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Baseline Melasma Area and Severity Index (MASI) scores (time frame: Measurements were done at baseline and during subsequent follow-ups at 4 weeks and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.