Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
Study NCT ID:
NCT04470466
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-07-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2020-07-04', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the percentage of decrease in size of enlarged facial pores assessed clinically and by dermoscopy', 'timeFrame': '2 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Skin Lesion']}, 'descriptionModule': {'briefSummary': 'Facial pores are visible topographic features of the skin that reflect openings of pilosebaceous follicles, that may be enlarged causing distress to some individuals. Many patients desire treatment for this condition, which can be an early sign of skin aging. Therapeutic modalities include intense pulsed light, radiofrequency, dermabrasion, oral and topical retinoids, as well as chemical peeling. Lasers, as fractional CO2, short pulse and Q-switched Nd-YAG, can potentially be used in treatment of wide pores.\n\nThis study aims at the assessment and comparison of therapy with short pulsed and Q-switched Nd-YAG laser plus topical carbon with fractional CO2 laser in the management of wide facial pores.', 'detailedDescription': 'topical carbon cream will be applied to one side of the face in patients with wide facial pores, followed by 2 passes of short pulse 1064 ND:YAG laser, then one pass of Q-switched ND-YAG laser.\n\nfractional CO2 laser will be performed to the other half of the face. the patients will receive 2 treatment sessions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are more than 18 years old with the large facial pores and are aware of their problem and seeking treatment\n\nExclusion Criteria:\n\n* • Previous laser therapy, chemical peeling, microdermabrasion or cosmetic procedure for the face.\n\n * Patients with any contraindication to laser therapy such as photosensitive diseases, skin malignancies, patients on oral retinoids.\n * Keloid-forming tendency.\n * Local or systemic treatment for skin pores in the previous 3 months\n * Connective tissue disease or the use of immunosuppressive medications.\n * Pregnancy.\n * Present or past history of herpes labialis.'}, 'identificationModule': {'nctId': 'NCT04470466', 'briefTitle': 'Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser in Treatment of Enlarged Facial Pores: A Split-face Comparative Study', 'orgStudyIdInfo': {'id': 'las49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'short pulse and Q-switched ND-YAG laser with topical carbon', 'interventionNames': ['Device: short pulse and Q-switched ND-YAG laser with topical carbon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fractional CO2 Laser', 'interventionNames': ['Device: fractional CO2 laser']}], 'interventions': [{'name': 'short pulse and Q-switched ND-YAG laser with topical carbon', 'type': 'DEVICE', 'description': 'application of topical carbon cream, followed by two passes of short pulse 1064 ND-YAG, then one pass of Q-switched 1064 ND-YAG on one side of the face', 'armGroupLabels': ['short pulse and Q-switched ND-YAG laser with topical carbon']}, {'name': 'fractional CO2 laser', 'type': 'DEVICE', 'description': 'single pass of fractional CO2 laser on the other side of the face', 'armGroupLabels': ['Fractional CO2 Laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Dina Saadi', 'investigatorAffiliation': 'Cairo University'}}}}