Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-04 @ 9:13 PM
Study NCT ID:
NCT04834167
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-04-02', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of the treatment', 'timeFrame': 'One month', 'description': 'Short Assessment of Patient Satisfaction (SAPS) questionnaire with additional Qualitative data collection; The score range for SAPS is from 0 (extremely dissatisfied) to 28 (extremely satisfied)'}], 'secondaryOutcomes': [{'measure': 'Feasibility of the recruitment and measurement tools', 'timeFrame': 'Pre-treatment, two weeks and one month', 'description': '1. Number of patients referred from OneDoc and eligible for screening\n2. Number of patients recruited\n3. Follow-up response rates (2 weeks and 1 month follow-ups)'}, {'measure': 'Treatment adherence', 'timeFrame': 'five months', 'description': 'Number of treatments attended'}, {'measure': 'Melasma', 'timeFrame': 'Through study completion, an average of 24 weeks', 'description': 'Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma)'}, {'measure': 'Quality of life of patients', 'timeFrame': 'Pre-treatment, two weeks and one month post-treatment', 'description': 'Melasma Quality of Life Scale (MELASQOL) score ranges from 10 to 70; Higher the score, worse is the quality of life'}, {'measure': 'Safety evaluation', 'timeFrame': 'immediately after and before each subsequent treatment', 'description': 'Incidence and severity of side effects caused by treatments'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melasma', 'Skin treatment', 'Picopulse', 'Malaysian women'], 'conditions': ['Skin Diseases', 'Skin Disorder', 'Melanoma (Skin)']}, 'referencesModule': {'references': [{'pmid': '30215845', 'type': 'RESULT', 'citation': 'Amini F, Thazin Oo NM, Okechukwu PN, Seghayat MS, Ng ESC. Polymorphisms in P53 and VEGFA genes in different subtypes of periorbital hyperpigmentation in a Malaysian Chinese population. Australas J Dermatol. 2019 May;60(2):e99-e104. doi: 10.1111/ajd.12918. Epub 2018 Sep 14.'}, {'pmid': '29020467', 'type': 'RESULT', 'citation': 'Chalermchai T, Rummaneethorn P. Effects of a fractional picosecond 1,064 nm laser for the treatment of dermal and mixed type melasma. J Cosmet Laser Ther. 2018 Jun;20(3):134-139. doi: 10.1080/14764172.2017.1376098. Epub 2017 Dec 4.'}, {'pmid': '30320904', 'type': 'RESULT', 'citation': 'Labadie JG, Krunic AL. Long pulsed dye laser with a back-to-back double-pulse technique and compression for the treatment of epidermal pigmented lesions. Lasers Surg Med. 2019 Feb;51(2):136-140. doi: 10.1002/lsm.23009. Epub 2018 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.', 'detailedDescription': 'This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women presenting dermal melasma with Fritzpatrick skin type III to V\n* Malaysian citizen\n* Agreed to participate\n* Provide informed consent\n\nExclusion Criteria:\n\n* Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months.\n* Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders\n* Patients who photosensitivity or taking drugs known to induce photosensitivity,\n* Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity\n* Patients who could not attend follow-up treatments'}, 'identificationModule': {'nctId': 'NCT04834167', 'briefTitle': 'OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Tunku Abdul Rahman'}, 'officialTitle': 'OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women', 'orgStudyIdInfo': {'id': 'UTAR-45-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Eligible patients will receive ten picopulse treatments for bi-monthly.', 'interventionNames': ['Device: OneDoc Picopulse']}], 'interventions': [{'name': 'OneDoc Picopulse', 'type': 'DEVICE', 'description': 'Eligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cheras', 'country': 'Malaysia', 'facility': 'OneDoc', 'geoPoint': {'lat': 3.108, 'lon': 101.726}}], 'overallOfficials': [{'name': 'Yang Mooi Lim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Tunku Abdul Rahman'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Tunku Abdul Rahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director (Institute of Postgraduate Studies and Research), Professor', 'investigatorFullName': 'Yang Mooi Lim', 'investigatorAffiliation': 'Universiti Tunku Abdul Rahman'}}}}