Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT05206318
Status:
UNKNOWN
Last Update Posted:
2022-01-25
First Post:
2022-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017495', 'term': 'Hyperpigmentation'}], 'ancestors': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003543', 'term': 'Cysteamine'}], 'ancestors': [{'id': 'D008624', 'term': 'Mercaptoethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The packaging and labeling of the topical product were the same in both group. The subjects were randomized in by an interactive web response system that provided study kit number from the randomization list at the time of inclusion into the study. The randomization list was kept strictly confidential throughout the study and was not available to the investigator and patient or any other personnel who may influence the study data.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial, Double masked, double-blinded'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-23', 'studyFirstSubmitDate': '2022-01-23', 'studyFirstSubmitQcDate': '2022-01-23', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Pigmentation at 4 Weeks', 'timeFrame': '4 weeks', 'description': 'Patients will have their lesion pigmentation scored with the hyperpigmentation index after 4 weeks'}, {'measure': 'Change from Baseline Pigmentation at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Patients will have their lesion pigmentation scored with the hyperpigmentation index after 8 weeks'}, {'measure': 'Change from Baseline Pigmentation at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Patients will have their lesion pigmentation scored with the hyperpigmentation index after 12 weeks'}, {'measure': 'Change from Baseline Pigmentation at 16 Weeks', 'timeFrame': '16 weeks', 'description': 'Patients will have their lesion pigmentation scored with the hyperpigmentation index after 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cysteamine', 'Postinflammatory Hyperpigmentation', 'Randomized control trial', 'Double blinded'], 'conditions': ['Hyperpigmentation; Postinflammatory']}, 'referencesModule': {'references': [{'pmid': '34591360', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32981068', 'type': 'RESULT', 'citation': 'Nguyen 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.'}, {'pmid': '32585079', 'type': 'RESULT', 'citation': "Karrabi 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."}, {'pmid': '28678558', 'type': 'RESULT', 'citation': 'Farshi 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.'}, {'pmid': '25251767', 'type': 'RESULT', 'citation': 'Mansouri 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.'}, {'pmid': '32879998', 'type': 'RESULT', 'citation': 'Karrabi 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 20 years old\n* Patients with postinflammatory hyperpigmentation for more than 3 months.\n\nExclusion Criteria:\n\n* Patients with topical hydroquinone, oral tranexamic acid and/or other skin whitening agents.\n* Patients that receive or planning to receive laser treatment for spot removal during the study period.\n* Individuals with allergic history to cysteamine or vehicle ingredients.\n* Pregnant patients or patients planning to become pregnant during the time of the study.'}, 'identificationModule': {'nctId': 'NCT05206318', 'briefTitle': 'Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation: A Randomized Control, Double Blinded-trial', 'orgStudyIdInfo': {'id': 'IRB202101456A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20 participants with topical cysteamine cream', 'description': 'Participants with post-inflammatory hyperpigmentation will apply topical cysteamine cream for a 16 weeks period.', 'interventionNames': ['Drug: Topical Cysteamine']}, {'type': 'SHAM_COMPARATOR', 'label': '20 participants with topical vehicle control cream', 'description': 'Participants with post-inflammatory hyperpigmentation will apply topical vehicle-control cream for a 16 weeks period.', 'interventionNames': ['Drug: Topical Vehicle Control']}], 'interventions': [{'name': 'Topical Cysteamine', 'type': 'DRUG', 'otherNames': ['Cyspera'], 'description': 'Topical cysteamine cream applied to the postinflammatory hyperpigmentation dark spots 15 minutes per day, followed by a face wash and moisturizing cream.', 'armGroupLabels': ['20 participants with topical cysteamine cream']}, {'name': 'Topical Vehicle Control', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['20 participants with topical vehicle control cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33305', 'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chau Yee Ng, MD', 'role': 'CONTACT', 'email': 'cyng87@cgmh.org.tw', 'phone': '+886-3-3281200', 'phoneExt': '3556'}], 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scientis Pharma SA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}