[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dystrophic-epidermolysis-bullosa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dystrophic-epidermolysis-bullosa":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,102,127,156,180,203],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100561763","phase-2-a-phase-2-study-of-tcp-25-gel-in-patients-with-epidermolysis-bullosa-step-study-100561763",false,"NCT06594393","A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study","A Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Topically Applied TCP-25 in Patients With Epidermolysis Bullosa","STEP","Inclusion Criteria:\n\n* Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and\u002For by a skin biopsy with immunofluorescence mapping.\n* Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use.\n\nExclusion Criteria:\n\n* The patient has any subtype of EB other than DEB or JEB.\n* The patient is currently being treated or planned to be treated with systemic antibiotics.\n\nNote: Use of preventive and\u002For anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited.\n\n• Use of systemic corticosteroids \\>0.2 mg\u002Fkg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit.\n\nNote: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.\n\n• The patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.","ALL","4 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB. The study will implement intrasubject randomization, ie, a pair of matching index wounds will be randomly assigned to be treated with a local application of either TCP 25 gel or vehicle gel.",[27,28,29],"Epidermolysis Bullosa (EB)","Dystrophic Epidermolysis Bullosa","Junctional Epidermolysis Bullosa",[31,32],"epidermolysis bullosa","topical treatment","RECRUITING","2026-05-19",{"date":36,"type":37},"2026-05-20","ACTUAL",{"date":39,"type":37},"2026-01-30",{"date":41,"type":21},"2027-06-30",{"name":43,"class":44},"Xinnate AB","INDUSTRY",9,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100593834","phase-1-targeting-collagen-vii-antibodies-in-bullous-diseases-using-efgartigimod-iv-vyvgart-100593834","NCT07011589","Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)","Inclusion Criteria:\n\n* For DEB patients (aged 12 years or older): DEB confirmed with mutation analysis and correlated by phenotype, and treatment of at least 1 wound treated with topical gene therapy (VYJUVEK). Presence of C7 antibodies above normal cutoff on ELISA.\n* For (classic) EBA patients (aged 18 years or older): EBA confirmed with positive histopathology (DIF), C7 antibodies above normal cutoff on ELISA, and having at least 1 skin lesion.\n* The participant has a Karnofsky performance status of at least 60% at screening.\n* Contraceptive use by reproductive male and female patients should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and:\n\n  1. Male participants:\n\n     \\- Must agree to use an acceptable method of contraception and not donate sperm from the time that the ICF is signed until they have received their last dose of IMP.\n  2. Female participants:\n\n     * Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at week 1 \u002F baseline before study intervention can be administered. Subsequent urine pregnancy tests are to be completed at week 6, week 11, week 16, week 21, and week 26 \u002F EoS.\n     * WOCBP must agree to use a highly effective or acceptable contraception method until at least 90 days after they receive their last dose of IMP.\n\nExclusion Criteria:\n\n* Linear IgA dermatosis-like EBA or other autoimmune blistering diseases (including but not limited to pemphigus vulgaris, bullous pemphigoid, mucous membrane pemphigoid).\n* Use of the following EBA treatments:\n\n  * sulfasalazine, IVIg, subcutaneous administration of immunoglobulin (SCIg), immunoadsorption or plasma exchange within 2 weeks of the screening visit, tetracyclines with or without nicotinamide at doses higher than the recommended daily allowance (RDA)\u002Fdietary reference intake (DRI) within 2 weeks of the screening visit.\n  * any monoclonal antibody (including rituximab or another anti-CD20 biologic) within 6 months of the screening visit.\n  * complementary therapies-such as traditional Chinese medicines, herbs, or procedures (e.g., acupuncture)-within 4 weeks (or 5 half-lives) of the screening visit, if the investigator determines that such therapies may interfere with the study's efficacy assessments and\u002For potentially risk the safety of the participant.\n  * The use of the following EBA treatments is permitted throughout the study: OCS, topical corticosteroids, conventional immunosuppressants (e.g., azathioprine, cyclophosphamide, methotrexate, mycophenolate, or mofetil), and dapsone.\n* Moderate to severe renal insufficiency.\n* Known contraindication to OCS therapy.\n* Clinically significant uncontrolled active or chronic, bacterial, viral, or fungal infection at screening\n* Medical instability limiting ability to travel to the Investigative Center\n* Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits\u002Fprocedures, as determined by the investigator.\n* Subjects actively receiving chemotherapy or immunotherapy at screening\n* Active drug or alcohol addiction as determined by the investigator.\n* Pregnant or nursing women\n* History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time, provided they are adequately treated prior to screening:\n\n  1. Basal cell or squamous cell skin cancer\n  2. Carcinoma in situ of the cervix\n  3. Carcinoma in situ of the breast\n  4. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)","12 Years",{"count":54,"type":21},18,[56,24],"PHASE1","The study objective is to see if IV Efgartigimod and Vyjuvek treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and IV Efgartigimod treatment in Epidermolysis Bullosa Acquisita (EBA) improves wound healing and affects the levels of C7 antibody levels in serum.\n\nFewer wounds, more rapidly healing wounds, and decreased C7 antibodies could improve quality of life.",[27,59,60,28],"Epidermolysis Bullosa Acquisita","Recessive Dystrophic Epidermolysis Bullosa",[31,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"epidermolysis bullosa acquisita","dystrophic epidermolysis bullosa","recessive dystrophic epidermolysis bullosa","recessive","dystrophic","epidermolysis","bullosa","acquisita","collagven 7","c7","Col7","EB","EBA","DEB","RDEB","antibodies","Collagen VII","VII","IV IgG","IgG","IV","IVIgG","C7 antibodies","Collagen 7 antibodies","Collagen VII Antibodies","Vyjuvek","B-VEC","Efgartigimod","NOT_YET_RECRUITING","2026-04-29",{"date":93,"type":37},"2026-05-05",{"date":95,"type":21},"2026-07",{"date":97,"type":21},"2028-01",{"name":99,"class":100},"M. Peter Marinkovich","OTHER",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":80,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":101},"100580187","phase-1-targeting-collagen-vii-antibodies-with-iv-igg-in-dystrophic-epidermolysis-bullosa-100580187","NCT06834035","Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa","Inclusion Criteria:\n\n1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.\n2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range\n3. Baseline skin blistering greater than 5% total body surface area\n4. 1 wound at least 20 cm\\^2 able to be entirely treated with Vyjuvek weekly\n5. 1 wound at least 20 cm\\^2 that has never been treated with Vyjuvek\n6. Ongoing VYJUVEK treatment.\n\nExclusion Criteria:\n\n1. History of thrombotic event(s)\n2. History of cardiac failure\n3. History of renal failure\n4. IgA deficiency","6 Years",{"count":110,"type":21},8,[56,24],"The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum.\n\nFewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.",[114,59,28,60],"Epidermolysis Bullosa",[114,59,28,60,116,117,72,73,74,75,76,118,78,80,81,83,119,120,86,87,88],"Collagen 7","C7","Antibodies","C7 Antibodies","Collagen 7 Antibodies",{"date":93,"type":37},{"date":123,"type":37},"2025-08-04",{"date":125,"type":21},"2027-03",{"name":99,"class":100},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100594231","phase-3-a-study-comparing-kb803-and-matched-placebo-in-patients-with-dystrophic-epidermolysis-bullosa-100594231","NCT07016750","A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa","A Double-Blind Crossover of KB803 and Matched Placebo for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa","IOLITE","Inclusion Criteria:\n\n1. The subject and\u002For their parent\u002Flegal guardian must provide informed consent\u002Fassent and must be able to and willing to follow study procedures and instructions.\n2. Age 6 months or older at time of informed consent\u002Fassent.\n3. Confirmed diagnosis of DEB with a mutation in the COL7A1 gene.\n4. Meets minimum corneal abrasion symptom frequency in the NHS study.\n\nExclusion Criteria:\n\n1. Initiation of any new treatment regimen or change in treatment for ocular disease during the run-in period except for preservative free topical antibiotics or artificial tears\u002Flubricants associated with standard of care treatment of corneal abrasions.\n2. Treatment with an investigational agent or off-label ophthalmic use of an approved product during the run-in period or planned use during the study (Exceptions may be approved by the medical monitor on a case-by-case basis).\n3. Any condition that, in the opinion of the Investigator, would impact the completion of all study-related assessments, interfere with the administration of study drug, and\u002For poses an additional risk to the subject.\n4. Women who are pregnant or nursing.\n5. Subject who is unwilling to comply with contraception requirements per protocol.\n6. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.","6 Months",{"count":137,"type":21},16,[139],"PHASE3","KB803-EYE-01 is a Phase 3 double-blind, randomized, placebo-controlled, crossover study to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB).",[28,142,60,143],"DEB - Dystrophic Epidermolysis Bullosa","Dominant Dystrophic Epidermolysis Bullosa",[28,75,145],"Corneal Abrasions","2026-03-11",{"date":148,"type":37},"2026-03-12",{"date":150,"type":37},"2025-06-20",{"date":152,"type":21},"2026-12",{"name":154,"class":44},"Krystal Biotech, Inc.",5,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":101},"100610641","phase-1-effect-of-evfv-on-wound-healing-in-dystrophic-epidermolysis-bullosa-100610641","NCT07230223","Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa","Safety and Efficacy of Ev.FV in Epidermolysis Bullosa Patients, A Randomized Clinical Trial, Phase 1 , 2","Inclusion Criteria:\n\n* DEB participants determined by electron microscopy, or genetic testing. Individuals with severe DEB (eg, RDEB patients with an absence of collagen VII) and milder forms of DEB (eg, RDEB patients with reduced levels of collagen VII) will be eligible.\n* People with one or more active wounds (each between 10 and 50 square centimeters on the arms, legs or trunk.)\n* Participants must be willing to comply with the requirements of the protocol and have consent to participate in the project.\n* Participants must be negative in the urine drug screening visit.\n\nExclusion Criteria:\n\n* Participants with clinical evidence of systemic infection.\n* Participants have a history of bone marrow transplantation.\n* Participants must have evidence of autoimmune disease, including insulin-dependent diabetes.\n* Participant has evidence of significant wound healing prior to treatment (ie, wound closure ≥ 20% during treatment at the first observation period).\n* Participant has a severe medical condition, such as malignancy (including skin cancer), life expectancy less than 2 years, which limits movement to the clinical center.\n* Participants have a current history of alcohol or substance abuse or a history of alcohol or substance abuse that requires treatment in the past 12 months.\n* People participating in the screening should have a positive hepatitis and human immunodeficiency virus (HIV) test result.\n* Women who are pregnant, lactating or planning to become pregnant during the study\n* Women who are of reproductive age and use birth control pills.","3 Years","35 Years",{"count":166,"type":21},20,[56,24],"Epidermolysis bullosa (EB) is a hereditary disease of skin tissues that causes painful bleeding blisters in the skin and mucous membrane. The prevalence of this disease is 1 in 50,000. The severity of the disease varies depending on the type of disease and may even lead to death. This disease is caused by a genetic mutation in keratin or collagen, and its incidence is the same in all men and women of different human races. In these patients, the skin becomes extremely fragile and peels off with the slightest scratch. Many blisters are one of the most obvious symptoms of this disease. The possibility of skin cancer in people suffering from this disease is more than others.\n\nNowadays, the preference of cell therapy methods is to use biological products produced by cells such as extracellular vesicles and mitochondria instead of stem cells. The use of Extracellular vesicles and engineered EVs as messenger carriers can introduce a new treatment method based on cell products for skin regeneration and as an alternative to cell therapy.\n\nTherefore, in this study, EV.FV will be applied topically to patients.",[28,170],"Wound Heal","2025-11-14",{"date":173,"type":37},"2025-11-17",{"date":175,"type":37},"2024-01-09",{"date":177,"type":21},"2026-12-25",{"name":179,"class":100},"Isfahan University of Medical Sciences",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100375833","phase-1-msc-evs-in-dystrophic-epidermolysis-bullosa-100375833","NCT04173650","MSC EVs in Dystrophic Epidermolysis Bullosa","Mesenchymal Stem Cell Extracellular Vesicles for the Treatment of Recessive Dystrophic Epidermolysis Bullosa Wounds","Inclusion Criteria:\n\n1. Subjects must be 6 months or older at screening.\n2. Subjects who have a confirmed diagnosis of DEB based on electron microscopy, immunomapping, or genetic testing. Subjects with severe DEB (e.g., RDEB patients with absent Col VII\u002Fno anchoring fibrils) and milder forms of DEB (e.g., RDEB patients with reduced Col VII and\u002For anchoring fibril levels) are eligible.\n3. Presence for at least four weeks of two 10 - 50 cm2 wounds (unroofed EB erosions) at least 4 inches apart that can be considered similar enough in size, wound location and expected healing characteristics to be a matched pair. Neither index wound may have been treated with any local (topical, subcutaneous, etc) or systemic therapeutic other than standard of care treatments described in this protocol (i.e. local or systemic antimicrobials to control infection, topical anesthetic and oral analgesics if required) in the past 3 months prior to screening.\n4. Females of childbearing potential must have a negative urine or serum pregnancy test at screening and agree to continue use of an acceptable form of birth control throughout the duration of the study. Acceptable forms of birth control include oral, implant, injectable, and transdermal contraceptives; an intrauterine device; or other forms considered acceptable by the investigator. A female subject is eligible to participate if she is not pregnant, is not a woman or childbearing potential (WOCBP), or is a WOCBP who agrees to follow the contraceptive guidance above.\n5. Post-pubertal males who agree to use an acceptable method of contraception for the duration of the study.\n6. Subjects 18 years of age and older must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Subjects under the age of 18 years must be capable of giving assent (if age-appropriate), and\u002For they must have a guardian capable of providing consent.\n7. Willing to comply with the protocol requirements.\n\nNote: Reference to Appendix 3 can be located in the protocol\n\nExclusion Criteria:\n\n1. Concomitant treatment at the time of screening or at any time during the study of either study wound (control or AGLE-102 treated) with local or systemic therapy other than standard of care treatments described in this protocol (i.e. local or systemic antimicrobials to control infection, topical anesthetic and oral analgesics if required). Concomitant treatment of non-study wounds with local therapy during the study is acceptable. Systemic treatment of RDEB wounds (except as noted for standard of care) during the study is not acceptable. Subjects unwilling to abstain from prohibited concomitant treatment of study wounds (treated or control) and\u002For systemic treatment of RDEB wounds during the study period are excluded.\n2. Either study wound located within 6 inches of wounds treated concurrently with any other local therapy.\n3. Clinical evidence of systemic infection.\n4. History of bone marrow transplantation.\n5. Diagnosed clinically significant autoimmune disease\n6. Wound that extends across the fingers, toes, pubic or perineum region are excluded from being index wounds.\n7. The subject has clinical evidence of an active infection at the wound site.\n8. Current malignancy (including skin cancer), a life expectancy of \\\u003C 2 years, or severe cardiopulmonary disease that restricts ambulation to the clinical facility.\n9. History of coagulopathy.\n10. Chronic use of systemic steroids or immunosuppressive agents.\n11. Allergy to human albumin, streptomycin, or penicillin.\n12. The subject is likely to be a recipient of tissue or organ transplantation.\n13. Current history of alcohol or substance abuse or has a history of alcohol or substance abuse that required treatment within the previous 12 months.\n14. History of poor compliance or unreliability.\n15. Females who are pregnant, nursing, or planning a pregnancy during their participation in the study.\n16. Concurrent participation in another investigational drug, biologic or device study that could confound study data.",{"count":110,"type":21},[56,24],"INVESTIGATIONAL PRODUCT: AGLE-102 is an allogeneic extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs).\n\nINDICATION AND RATIONALE: The aim of the study is to assess the safety and efficacy of AGLE-102 in the treatment of lesions in subjects with Epidermolysis Bullosa (EB).\n\nSTUDY DESIGN: This is a phase 1\u002F2A, randomized, multi-center, study to assess the effectiveness and safety of AGLE-102 on lesions in subjects with EB.",[28],[192,193],"Exosomes","Extracellular Vesicles",{"date":195,"type":37},"2025-06-25",{"date":197,"type":37},"2024-08-13",{"date":199,"type":21},"2026-03",{"name":201,"class":44},"Aegle Therapeutics",3,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":202},"100432959","long-term-follow-up-protocol-100432959","NCT04917887","Long-Term Follow-up Protocol","A Prospective, Observational, Long-Term Follow-Up (LTFU) Study to Evaluate the Long-Term Safety of the Krystal Biotech, Inc. Gene Therapy Backbone Products Using HSV-1 Backbone","Inclusion Criteria:\n\n* All adult and pediatric participants who received at least one gene therapy treatment in a previous Krystal Biotech, Inc. sponsored study, and have discontinued or completed the parent treatment protocol (which do not have the LTFU embedded into the parent protocol), as applicable.\n* Consent\u002FAssent must be obtained by the participants (and, parental\u002Flegal representative, when applicable) prior to any study-related data being collected.\n* Participant is willing and able to adhere to the protocol requirements.\n\nExclusion Criteria:\n\n* Participants who enroll into a non-Krystal Biotech, Inc. interventional gene therapy clinical trial will be excluded from the study.",{"count":211,"type":21},50,"OBSERVATIONAL","The main objective of this prospective, observational, long-term follow-up (LTFU) study is to evaluate the long-term safety profile of the gene therapy products evaluated by Krystal Biotech, Inc. which have a shared backbone of HSV-1, in participants who received at least one dose of investigational product (IP).",[28,60,143],"2021-06-07",{"date":217,"type":37},"2021-06-08",{"date":219,"type":37},"2021-05-25",{"date":221,"type":21},"2028-05-25",{"name":154,"class":44}]