Hyperpigmentation; PostinflammatoryNCT05206318
Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation
A study testing Topical Cysteamine in people with Hyperpigmentation; Postinflammatory, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation; Postinflammatory
- What is being tested?
- Topical Cysteamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Dec 2021to 10 Dec 2022
- Phase
- Interventional
- 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
- Over 20 years old
- Patients with postinflammatory hyperpigmentation for more than 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City, 33305
Chau Yee Ng, MD, +886-3-3281200 ext. 3556, cyng87@cgmh.org.tw
About this study
Official title: Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation: A Randomized Control, Double Blinded-trial
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.
Read the 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.
- Conditions
- Hyperpigmentation; Postinflammatory
- Being tested
- Topical Cysteamine, Topical Vehicle Control
- Keywords
- Cysteamine, Postinflammatory Hyperpigmentation, Randomized control trial, Double blinded
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical CysteamineDrug
Also called Cyspera
Topical cysteamine cream applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream.
Topical Vehicle ControlDrug
Topical vehicle control cream without cysteamine active ingredients applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream.
| Study group | Role | What they receive |
|---|---|---|
| 20 participants with topical cysteamine cream | Experimental | Participants with post-inflammatory hyperpigmentation will apply topical cysteamine cream for a 16 weeks period. Receives: Drug: Topical Cysteamine |
| 20 participants with topical vehicle control cream | Sham comparator | Participants with post-inflammatory hyperpigmentation will apply topical vehicle-control cream for a 16 weeks period. Receives: Drug: Topical Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pigmentation at 4 Weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 4 weeks
Measured: 4 weeks
Change from Baseline Pigmentation at 8 Weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 8 weeks
Measured: 8 weeks
Change from Baseline Pigmentation at 12 Weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 12 weeks
Measured: 12 weeks
Change from Baseline Pigmentation at 16 Weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start10 Dec 2021
- Primary completion10 Jun 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hyperpigmentation; PostinflammatoryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial, Double masked, double-blinded
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Scientis Pharma SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206318
- Sponsor's protocol ID
- IRB202101456A3
- Status last verified
- Dec 2021
- First submitted
- 23 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34591360Nguyen 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.
PubMed 32981068Karrabi 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.
PubMed 32585079Farshi 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.
PubMed 28678558Mansouri 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.
PubMed 25251767Karrabi 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.
PubMed 32879998
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation: A Randomized Control, Double Blinded-trial
- ClinicalTrials.gov ID
- NCT05206318
- Acronym / sponsor ID
- IRB202101456A3
- Conditions
- Hyperpigmentation; Postinflammatory
- Keywords
- Cysteamine, Postinflammatory Hyperpigmentation, Randomized control trial, Double blinded
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Scientis Pharma SA
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 25 Jan 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized control trial, Double masked, double-blinded
| Arm | Type | Receives |
|---|---|---|
| 20 participants with topical cysteamine cream | Experimental | Drug: Topical CysteamineParticipants with post-inflammatory hyperpigmentation will apply topical cysteamine cream for a 16 weeks period. |
| 20 participants with topical vehicle control cream | Sham comparator | Drug: Topical Vehicle ControlParticipants with post-inflammatory hyperpigmentation will apply topical vehicle-control cream for a 16 weeks period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 20 years old
- Patients with postinflammatory hyperpigmentation for more than 3 months.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Topical CysteamineAlso: CysperaTopical cysteamine cream applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream. | Drug | 20 participants with topical cysteamine cream |
| Topical Vehicle ControlTopical vehicle control cream without cysteamine active ingredients applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream. | Drug | 20 participants with topical vehicle control cream |
Primary outcome
Change from Baseline Pigmentation at 4 Weeks
Time frame: 4 weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 4 weeks
Change from Baseline Pigmentation at 8 Weeks
Time frame: 8 weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 8 weeks
Change from Baseline Pigmentation at 12 Weeks
Time frame: 12 weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 12 weeks
Change from Baseline Pigmentation at 16 Weeks
Time frame: 16 weeks
Patients will have their lesion pigmentation scored with the hyperpigmentation index after 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Results publication: PubMed 34591360Ahramiyanpour 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.
- Results publication: PubMed 32981068Nguyen 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.
- Results publication: PubMed 32585079Karrabi 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.
- Results publication: PubMed 28678558Farshi 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.
- Results publication: PubMed 25251767Mansouri 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.
- Results publication: PubMed 32879998Karrabi 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Cysteamine in people with Hyperpigmentation; Postinflammatory, run by Chang Gung Memorial 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pigmentation at 4 Weeks (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05206318, which also lists 6 linked publications.
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 25 Jan 2022.