Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-08 @ 12:10 AM
Study NCT ID:
NCT02544958
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2015-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Er:YAG Laser for Treatment of Enlarged Pores
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053844', 'term': 'Lasers, Solid-State'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-31', 'studyFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2015-09-08', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of Er:YAG laser in the treatment of enlarged pores (measurement of skin texture using UVA-light video camera)', 'timeFrame': '1 month after 4 treatments', 'description': 'measurement of skin texture using UVA-light video camera'}], 'secondaryOutcomes': [{'measure': 'Hyperpigmentation side effect of Er:YAG laser in the treatment of enlarged pores', 'timeFrame': 'Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment', 'description': "By investigators' observation of hyperpigmentation"}, {'measure': 'Hypopigmentation side effect of Er:YAG laser in the treatment of enlarged pores', 'timeFrame': 'Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment', 'description': "By investigators' observation of hypopigmentation"}, {'measure': 'Erythema side effect of Er:YAG laser in the treatment of enlarged pores', 'timeFrame': 'Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment', 'description': "By investigators' observation of erythema"}, {'measure': 'The patients satisfaction using Quartile grading scale of improvement', 'timeFrame': 'Follow-up period:1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment and 1-,3-,and 6-month after 4th treatment', 'description': 'By using Quartile grading scale of improvement; 0 = not improve, 1= 1-25% improvement, 2 = 26-50% improvement, 3 = 51-75% improvement and 4 = 76-100% improvement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Enlarged pores', 'Er:YAG laser'], 'conditions': ['Enlarged Pores']}, 'referencesModule': {'references': [{'pmid': '19125363', 'type': 'BACKGROUND', 'citation': 'Roh MR, Chung HJ, Chung KY. Effects of various parameters of the 1064 nm Nd:YAG laser for the treatment of enlarged facial pores. J Dermatolog Treat. 2009;20(4):223-8. doi: 10.1080/09546630802647244.'}, {'pmid': '24155526', 'type': 'BACKGROUND', 'citation': 'Roh M, Goo B, Jung J, Chung H, Chung K. Treatment of enlarged pores with the quasi long-pulsed versus Q-switched 1064 nm Nd:YAG lasers: A split-face, comparative, controlled study. Laser Ther. 2011;20(3):175-80. doi: 10.5978/islsm.20.175.'}, {'pmid': '24155527', 'type': 'BACKGROUND', 'citation': 'Chung H, Goo B, Lee H, Roh M, Chung K. Enlarged pores treated with a combination of Q-switched and micropulsed 1064 nm Nd:YAG laser with and without topical carbon suspension: A simultaneous split-face trial. Laser Ther. 2011;20(3):181-8. doi: 10.5978/islsm.20.181.'}, {'pmid': '17036285', 'type': 'BACKGROUND', 'citation': 'Kunzi-Rapp K, Dierickx CC, Cambier B, Drosner M. Minimally invasive skin rejuvenation with Erbium: YAG laser used in thermal mode. Lasers Surg Med. 2006 Dec;38(10):899-907. doi: 10.1002/lsm.20380.'}, {'pmid': '18318730', 'type': 'BACKGROUND', 'citation': 'Tay YK, Kwok C. Minimally ablative erbium:YAG laser resurfacing of facial atrophic acne scars in Asian skin: a pilot study. Dermatol Surg. 2008 May;34(5):681-5. doi: 10.1111/j.1524-4725.2008.34127.x. Epub 2008 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the treatment of enlarged pores.', 'detailedDescription': '* Enlarged pores are caused by multifactorial factors such as sex, genetics, aging, etc.\n* The gold of the treatment is to recollagenesis of the dermis and resurfacing of the epidermis.\n* Modalities that have been proved on their efficacy for enlarged pores treatment included topical retinoic acid, chemical peeling, intense pulsed light, radiofrequency device, laser such as Q-switched and Long Pulsed Neodymium-Doped Yttrium-Aluminum-Garnet (Nd:YAG) 1,064nm, Long pulse duration pulsed dye laser 595nm, etc.\n* Er:YAG laser is an ablative laser which creates both recollagenesis and resurfacing. It ha been proved to be safe and effective in the treatment of atrophic acne scar.\n* However, the efficacy of this laser for enlarged treatment has not yet been established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visible enlarged pores on both sides of the face\n* Fitzpatrick skin type 3-5\n\nExclusion Criteria:\n\n* Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind\n* Patients who have photosensitive dermatoses\n* Pregnancy and lactation woman\n* Patients with wound infections (herpes, other) on the day of treatment\n* Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo\n* Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care'}, 'identificationModule': {'nctId': 'NCT02544958', 'briefTitle': 'Er:YAG Laser for Treatment of Enlarged Pores', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Efficacy and Safety of Erbium:Yttrium Aluminum Garnet Laser for Treatment of Enlarged Pores: A Pilot Study', 'orgStudyIdInfo': {'id': 'Si 251/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Er:YAG laser', 'description': '4 treatments of 1 month interval', 'interventionNames': ['Device: Er:YAG laser']}], 'interventions': [{'name': 'Er:YAG laser', 'type': 'DEVICE', 'description': 'Er:YAG laser treats enlarged pores on both sides of the face for 4 treatments of 1 month interval.', 'armGroupLabels': ['Er:YAG laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Dermatology, Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Woraphong Manuskiatti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woraphong Manuskiatti, M.D.', 'investigatorAffiliation': 'Mahidol University'}}}}