Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-04-05 @ 5:25 AM
Study NCT ID:
NCT04539561
Status:
UNKNOWN
Last Update Posted:
2022-03-16
First Post:
2020-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hands pigmentation change assessed by investigator', 'timeFrame': '1 month follow up', 'description': 'Hands pigmentation change assessed by investigator at the 1 month follow up using the 5-point Pigment Improvement Score where score of between 0 and 4 will be assigned (0- No improvement in pigmentation, 1- Trace to mild improvement of some lesions, 2- Moderate response: some lesions lighter, 3- Good response: most lesions much lighter and 4- Excellent response- Most or all lesions much lighter or gone.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pigmentation']}, 'descriptionModule': {'briefSummary': 'A total of 20 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign hand pigmentation who wish to improve their skin appearance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Female/Male.\n* Age= 21-70 (Adults).\n* Fitzpatrick skin phototype = I-V\n* Congenital or acquired benign pigmentation on hands.\n* Presence of at least three (3) lesions with similar pigmentation intensity in the treatment area in diameters larger than 2 mm.\n* Able to read, understand and provide written Informed Consent.\n* Able and willing to comply with the treatment/follow-up schedule and requirements.\n* Women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study.\n\nExclusion Criteria:\n\n* History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.\n* Tanning (artificial or natural) 1 month prior first treatment and during the entire study duration including follow-up.\n* Excessive underlying vascular conditions (e.g. dense network of capillaries).\n* Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding.\n* Prior skin laser, light or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study.\n* Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.\n* Prior treatment with medium-depth or deeper, chemical peels or dermabrasion in treated area within 3 months of initial treatment or during the course of the study.\n* Any other surgery in treated area within 9 months of initial treatment or during the course of the study.\n* Hypersensitive to light exposure or the use of photosensitive medication for which light exposure is contraindicated.\n* Multiple dysplastic nevi or suspicious pigmentation in area to be treated.\n* Presence of underlying tattoo in the treatment area.\n* Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process.'}, 'identificationModule': {'nctId': 'NCT04539561', 'briefTitle': 'Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Focus Medical, LLC'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL', 'orgStudyIdInfo': {'id': 'Focus-PiQo4 Pigmentation-19-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pigmentation', 'description': 'Treatment of Hand Pigmentation Using PiQo4 Laser System', 'interventionNames': ['Device: PiQo4 Laser System']}], 'interventions': [{'name': 'PiQo4 Laser System', 'type': 'DEVICE', 'description': 'PiQo4 Laser System for treatment of hand pigmentation', 'armGroupLabels': ['Pigmentation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Firas Al-Niaimi, Dr.', 'role': 'CONTACT', 'phone': '+447956147543'}], 'facility': '"Sk;N" Clinic', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Firas Al-Niaimi, MD', 'role': 'CONTACT', 'email': 'Firas55@hotmail.com', 'phone': '+447956147543'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Focus Medical, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}