Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-10 @ 9:06 PM
Study NCT ID:
NCT03279003
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2017-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin
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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2017-09-01', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of light therapy', 'timeFrame': '2 months', 'description': 'The improvement of sensitive skin symptoms will be measured by the Sensiscale scale'}], 'secondaryOutcomes': [{'measure': 'Assessment of pain improvement', 'timeFrame': '2 months', 'description': 'Pain improvement will be done by self-evaluation of the patients, using a visual analog scale'}, {'measure': 'Assessment of improvement in pruritus', 'timeFrame': '2 months', 'description': 'The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale'}, {'measure': 'Assessment of the tolerance', 'timeFrame': '2 months', 'description': "At the end of the study, patients will be questioned about the possible occurrence of side effects listed in the patient's notebook during the 8 weeks of treatment."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensitive Skin']}, 'referencesModule': {'references': [{'pmid': '32118019', 'type': 'RESULT', 'citation': 'Sonbol H, Brenaut E, Nowak E, Misery L. Efficacy and Tolerability of Phototherapy With Light-Emitting Diodes for Sensitive Skin: A Pilot Study. Front Med (Lausanne). 2020 Feb 7;7:35. doi: 10.3389/fmed.2020.00035. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Light-emitting diode (LED) light therapy is increasingly used successfully and without adverse effects in diabetic leg ulcer, chronic low back pain, chronic myofacial pain in the neck and in several dermatoses such as acne, Psoriasis, alopecia areata and skin rejuvenation. A Korean study conducted in 2013 suggested its effectiveness in patients with sensitive skin in connection with rosacea, acne, eczema. The objective of the study is to perform a study in subjects with a sensitive skin without associated dermatosis.', 'detailedDescription': 'The objective of the study is to evaluate the efficacy of light-emitting diode therapy in subjects with sensitive skin and to assess pain improvement, evaluation of improvement in pruritus and evaluation of treatment tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Age less than or equal to 70\n* Sensitive skin defined by a score ≥ 40 on the Sensiscale scale\n* Patient able to consent\n\nExclusion Criteria:\n\n* Persons under 18 years of age or over.\n* Persons suffering from disorders of higher functions preventing comprehension of the questionnaire.\n* Pregnancy.\n* Analgesic or medication acting on the nervous system.\n* Other dermatosis of the face (example: rosacea, seborrheic dermatitis, acne ...).\n* Neurological or psychiatric illness.\n* A photosensitizing drug.\n* Refusal of patient\n* Patients under legal protection'}, 'identificationModule': {'nctId': 'NCT03279003', 'acronym': 'SENSILED', 'briefTitle': 'Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Study of the Efficacy and Tolerance of Light Therapy by Light-emitting Diode (LED) in Sensitive Skin', 'orgStudyIdInfo': {'id': 'SENSILED (29BRC16.0179)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Light-emitting diode therapy', 'description': 'Exposure to LED light', 'interventionNames': ['Device: LED light']}], 'interventions': [{'name': 'LED light', 'type': 'DEVICE', 'description': 'An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.', 'armGroupLabels': ['Light-emitting diode therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}