Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-01 @ 3:40 PM
Study NCT ID:
NCT04878692
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2021-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D005076', 'term': 'Exanthema'}, {'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale).', 'timeFrame': '6 weeks after the start of the anti-EGFR treatment.', 'description': 'Measurement of Onco-Rash percentage of failure by counting the number of patients for whom a skin rash with a grade ≥ 2 (NCI-CTCAE scale) will occur between 0-6 weeks after the start of the anti-EGFR treatment. The introduction of an anti-inflammatory, a calming or an antibiotic treatment for acne will also be considered as failure.'}], 'secondaryOutcomes': [{'measure': 'Timing of apparition of grade 1, 2 or ≥ 2 skin eruption: number of days between the start of the anti-EGFR treatment and the apparition of a skin eruption.', 'timeFrame': '6 weeks after the start of the anti-EGFR treatment.', 'description': 'Comparison of timing of apparition of grade 1, 2 or ≥ 2 skin eruption between the Onco-Rash arm and the Onco-Neutral arm.'}, {'measure': 'Percentage of patients with a grade 1, 2 or ≥ 2 skin eruption', 'timeFrame': '6 weeks after the start of the anti-EGFR treatment.', 'description': 'Number of patients for whom a grade 1, 2 or ≥ 2 skin eruption have been reported'}, {'measure': 'Percentage of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been introduced', 'timeFrame': '6 weeks after the start of the anti-EGFR treatment.', 'description': 'Number of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been prescribed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin Rash', 'anti-EGFR therapy', 'Cosmetic Product', 'Acne', 'Cancer patients'], 'conditions': ['Carcinoma, Non-Small-Cell Lung', 'Colorectal Neoplasms', 'Head and Neck Neoplasms']}, 'descriptionModule': {'briefSummary': "It is important for patients treated with anti-EGFR therapies to get access to cosmetic options to preserve their skin condition during treatment. Anti-EGFR therapies are known to fragilize epidermis and to provoke rashes; which often lead to treatment discontinuation.\n\nThe aim of this study is to demonstrate that the Onco-Rash cream is able to preserve skin condition without side effects. Decreasing skin toxicity is expected to improve patients' life and facilitate treatment follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\> 18 years old\n* Patient naive from anti-EGFR treatment (gefitinib, erlotinib, afatinib, cetuximab panitumumab, osimertinib, alectinib et crizotinib, etc).\n* NSCLC (non-small cell lung cancer) patients eligible to anti-EGFR as first line treatment (gefitinib, erlotinib,afatinib, etc)\n* Colorectal cancer patients eligible to anti-EGFR as first line treatment (cetuximab, panitumumab,….)\n* Head and Neck/ENT (Ear, Nose Troat) cancer patients eligible to anti-EGFR as first line treatment (cetuximab,…)\n* Signed informed consent\n* Social security affiliation\n\nExclusion Criteria:\n\n* Pregnant or Breastfeeding patient\n* Patient in age to procreate without an efficient contraceptive method\n* Patient with previous experience of allergic or irritative contact dermatitis to components of the studied product\n* Patient with dermatologic conditions that cannot permit the study of skin toxicity of anti-EGFR\n* Patients under radiotherapy 8 days prior the inclusion date\n* Patient under immunotherapy 8 days prior the inclusion date\n* Patient with local or systemic antibiotic treatment for acne 8 days prior the inclusion date\n* Patient with antihistamines treatment 8 days prior the inclusion date\n* Patients taking NSAIDs or corticoids as chronic medication or that took NSAIDs or corticoids 5 days prior the inclusion date\n* Participation to another interventional study\n* Patient with an altered ECOG (Eastern Cooperative Oncology Group) state ( \\>2)\n* Patient deprived of liberty or subjected to guardianship\n* Impossibility to track and follow patient for geographical, social or psychiatric reasons.'}, 'identificationModule': {'nctId': 'NCT04878692', 'acronym': 'OPERA', 'briefTitle': 'Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of a Cosmetic Product (Onco-Rash) to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies Which Are Known to Fragilize Epidermis', 'orgStudyIdInfo': {'id': '69HCL20_0519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Onco-Rash arm', 'description': 'In this arm label, patients will apply the Onco-Rash cream on selected zones (face, neck, thorax,…) twice a day, during 6 weeks.\n\nThis arm will be compared to the Onco-Neutral arm, in which the Onco-Neutral cream will be applied on selected zones (face, neck, thorax,…) twice a day, during 6 weeks.', 'interventionNames': ['Drug: Application of Onco-Rash cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Onco-Neutre arm', 'description': 'In this arm label, patients will apply the Onco-Neutre cream on selected zones (face, neck, thorax,…) twice a day, during 6 weeks.\n\nOnco-Neutral cream will be used as an experimental comparator to Onco-Rash cream.\n\nThis arm will be compared to the Onco-Neutral arm, in which the Onco-Neutral cream will be applied on selected zones (face, neck, thorax,…) twice a day, during 6 weeks.', 'interventionNames': ['Drug: Application of Onco-Neutre cream']}], 'interventions': [{'name': 'Application of Onco-Rash cream', 'type': 'DRUG', 'description': 'The cream "Onco-Rash" will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage.', 'armGroupLabels': ['Onco-Rash arm']}, {'name': 'Application of Onco-Neutre cream', 'type': 'DRUG', 'description': 'The cream "Onco-Neutre" will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage.', 'armGroupLabels': ['Onco-Neutre arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'contacts': [{'name': 'Julien PERON, MD', 'role': 'CONTACT', 'email': 'julien.peron@chu-lyon.fr', 'phone': '478862339', 'phoneExt': '+33'}, {'name': 'Anne-Sophie BELMONT', 'role': 'CONTACT', 'email': 'anne-sophie.belmont@chu-lyon.fr', 'phone': '478864195', 'phoneExt': '+33'}], 'facility': 'Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Julien PERON, MD', 'role': 'CONTACT', 'email': 'julien.peron@chu-lyon.fr', 'phone': '478862339', 'phoneExt': '+33'}, {'name': 'Anne-Sophie BELMONT', 'role': 'CONTACT', 'email': 'anne-sophie.belmont@chu-lyon.fr', 'phone': '0478864195', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Julien PERON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie des Hospices Civils de Lyon - Service d'Oncologie médicale"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}