Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT01545869
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2012-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2012-03-02', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treatment success', 'timeFrame': 'One month', 'description': 'reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos'}], 'secondaryOutcomes': [{'measure': 'Treatment safety', 'timeFrame': 'three months', 'description': 'Absence of irreversible changes in color and texture of the facial skin, that can cause patient dissatisfaction'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['carbon dioxide laser', 'fractional resurfacing', 'freckles', 'melanosis'], 'conditions': ['Freckles']}, 'descriptionModule': {'briefSummary': 'Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a fair complexion patient, but may be present in other skin types.\n\nThe gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles, pigmentation, and general sun damage has been the carbon dioxide (CO2) laser since the mid 1990s. The traditional CO2 laser was very effective, however it fell out of favor because it required general anesthesia. It also had a prolonged recovery time. Over the last several years, advances in technology known as fractional resurfacing has made the CO2 laser popular again: Fractional CO2 laser treatment is one of the newest laser rejuvenation technology. It proved successful in treatment of melasma, one of the pigmented dermatoses. To the best of our knowledge, based on a thorough search of literature, no clinical studies assessing fractional CO2 laser in treatment of freckles could be retrieved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -Patients affected with facial freckles.\n* Age: 10 years or more\n\nExclusion Criteria:\n\n* Patients younger than 10 years old.\n* Patients aged 10-21 years who can not provide a written consent of parents or legal guardian.\n* Patients with known tendency to keloid or hypertrophic scar formation.\n* Patients receiving treatment with systemic retinoids or having stopped their course since less than six months duration.'}, 'identificationModule': {'nctId': 'NCT01545869', 'briefTitle': 'Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles', 'orgStudyIdInfo': {'id': 'Fractional CO2 in freckles'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fractional carbon dioxide laser', 'interventionNames': ['Procedure: Fractional carbon dioxide laser']}], 'interventions': [{'name': 'Fractional carbon dioxide laser', 'type': 'PROCEDURE', 'otherNames': ['Ablative fractional laser resurfacing'], 'description': 'SmartXide fractional carbon dioxide laser (DEKA, Florence, Italy). Parameters adjusted for: Power 20 watts, spacing 200 µsec, dwell time 300 µm, stacks 1.', 'armGroupLabels': ['Fractional carbon dioxide laser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Dermatology department - faculty of medicine- Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Bakr M Elzawahry, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Vanessa G Hafez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Aya Fahim, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr. Bakr Mohamed Elzawahry', 'investigatorAffiliation': 'Cairo University'}}}}