- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05378997
Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male and Female Volunteers to Investigate the Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds and in Patients With Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Lund, Sweden, SE-221 85
- Skåne University Hospital in Lund, Clinical Trial Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Part I:
Inclusion Criteria:
- Willing and able to give written informed consent for participation in the study.
- Healthy male or female subject 18-60 years (inclusive) of age at the time of signing the informed consent.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
- Healthy and intact skin where the blister suction wounds will be induced.
Women of childbearing potential (WOCBP) must have a documented negative serum pregnancy test done at the screening visit, within 4 weeks prior to suction blister formation and the start of study treatment.
WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose. Female subjects must refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner must agree to use a condom during the same time frame if he has not undergone vasectomy.
Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] 25-140 IE/L is confirmatory).
Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of last dosing until 3 months after the last dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above).
- Clinically relevant medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
Exclusion Criteria:
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Disease that may interfere with wound healing, e.g., diabetes type I/II, arterial-, renal-, liver, or cardiac insufficiency, chronic obstructive lung disease, cancer, autoimmune disease, edema at the study site, severe obesity, or previous known wound healing problems, as judged by the investigator.
- Active skin disease, e.g., dermatitis, psoriasis and wounds, and/or tattoos in the areas where suction blister wounds will be induced, as judged by the investigator.
- Any planned major surgery within the duration of the study.
After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic blood pressure <90 or >160 mmHg, or
- Diastolic blood pressure <50 or >100 mmHg, or
- Pulse <40 or >90 beats per minute (bpm)
- Any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
- Female subjects who are pregnant or lactating or planning a pregnancy.
- Systemic immunosuppressive treatment.
- Subjects who are currently receiving or have received the following treatments within 2 weeks prior to screening are excluded from the study: - systemic corticosteroids or immunosuppressant agents; or - antibiotics via any route
- Regular use of anticoagulants (i.e., heparin, warfarin, coumarins, other anticoagulants per Investigator's judgement) or non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to TCP-25 or to any excipients of the hydrogel.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Involvement in the planning and/or conduct of the study.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Part II:
Inclusion criteria:
- Willing and able to give written informed consent for participation in the study.
- Male patient, or female patient of non-childbearing potential, ≥40 years of age at the time of signing the informed consent.
Male subjects must be willing to use condom or be vasectomized or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of last dosing until 3 months after the last dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy.
Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] 25-140 IU/L is confirmatory).
- Clinically relevant medical history, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- Patients diagnosed with venous insufficiency by relevant physiological tests including doppler or venous plethysmography or diagnosed by relevant clinical evaluations.
- Systolic index > 0.6 (Data from medical records from the last 2 years, or the assessment should be repeated at the screening visit).
- Ulcer duration > 6 weeks
- Total target ulcer area applicable for treatment: ≤ 30 cm2 (as measured with the Silhouette imaging equipment at the screening visit). (The target ulcer area may not consist of >2 separate ulcers.)
- Ability to tolerate compression bandaging.
- Willing to attend study site visits.
Exclusion criteria:
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Disease that may interfere with wound healing, e.g., diabetes type I/II, arterial-, renal-, liver, or cardiac insufficiency, chronic obstructive lung disease, cancer, autoimmune disease, edema at the study site, severe obesity, or previous known wound healing problems, as judged by the Investigator.
- Active skin disease, e.g., dermatitis, psoriasis and wounds, and/or tattoos in the areas where suction blister wounds will be induced, as judged by the Investigator.
- Any planned major surgery within the duration of the study.
After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic blood pressure <90 or >160 mmHg, or
- Diastolic blood pressure <50 or >100 mmHg, or
- Pulse <40 or >90 beats per minute (bpm)
- Any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
- Female subjects who are pregnant or lactating or planning a pregnancy.
- Systemic immunosuppressive treatment.
Subjects who are currently receiving or have received the following treatments within 2 weeks prior to screening are excluded from the study:
- systemic corticosteroids or immunosuppressant agents; or
- antibiotics via any route
- Regular use of anticoagulants (i.e., heparin, warfarin, coumarins, other anticoagulants per Investigator's judgement) or non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to TCP-25 or to any excipients of the hydrogel.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Involvement in the planning and/or conduct of the study.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
9.5.2 Part II: Exclusion criteria
Patients must not enter the study if any of the following exclusion criteria are fulfilled:
- Presence or documented illness, which in the Investigator's opinion may negatively affect wound healing or interfere with the study conduct.
- Target wound present for more than 5 years.
- Clinical signs of infection in or around the wound in need of antibiotic treatment.
- Albumin <25 g/L or capillary Hb <90 g/L, or HbA1c > 70 mmol/mol at the time of the screening visit.
- Any planned major surgery within the duration of the study.
Patients who are currently receiving or have received the following treatments within 2 weeks prior to screening are excluded from the study:
- systemic corticosteroids above 5 mg prednisolone or equivalent, or
- immunosuppressant agents; or
- antibiotics via any route.
- Regular use of anticoagulants (i.e., heparin, warfarin, coumarins, other anticoagulants affecting APTT and/or PK/INR per Investigator's judgement) within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to TCP-25 or to any excipients of the hydrogel.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Involvement in the planning and/or conduct of the study.
- Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
Part III:
Inclusion criteria:
- Willing and able to give written informed consent for participation in the study. For 15 to 17-year-olds: A separate consent is required from both (if applicable) the patient's parents/legal guardians.
- Male or female patient with documented diagnosis of inherited DEB, ≥15 years of age at the time of signing the informed consent.
Male patients must be willing to use condom or be vasectomized or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of last dosing until 3 months after the last dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy.
WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the patient) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose. Female patients must refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner must agree to use a condom during the same time frame if he has not undergone vasectomy.
Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] 25-140 IU/L is confirmatory).
- Clinically relevant medical history at the time of screening, as judged by the Investigator.
Presence of two target wound areas of 50 cm2. The primary wound area should not be located at anatomical sites with high likelihood of accidental trauma (e.g., knee, elbow). The secondary wound area could be located at anatomical sites with high likelihood of accidental trauma or be within the higher age span. Both wound areas should meet all the following characteristics:
- Including open wound with a surface area of ≤ 30 cm2 (as measured with the Silhouette imaging equipment at the screening visit).
- At Visit 2 (first IMP treatment), each target wound should not present a surface reduction ≥ 30 % from the Screening visit.
- Wound aged ≥ 3 weeks to < 9 months at the Screening visit.
Presence of a reference wound area of 50 cm2 to be treated with standard of care only and to be included in the exploratory assessment. The wound area should match the primary wound area for following characteristics:
- Including open wound with a surface area of ≤ 30 cm2 (as measured with the Silhouette imaging equipment at the screening visit).
- At Visit 2 (first IMP treatment), the wound should not present a surface reduction ≥ 30 % from the Screening visit.
- Wound aged ≥ 3 weeks to < 9 months at the Screening visit.
- Not located at anatomical sites with high likelihood of accidental trauma (e.g., knee, elbow).
- Willing to attend study site visits.
Exclusion criteria
- Any subtype of EB other than DEB.
- EB index wounds that have infection in need of systemic antibiotic treatment.
- Presence of or documented illness, which in the Investigator's opinion may negatively affect wound healing or interfere with the study conduct.
- Subject has evidence of a systemic infection or has used systemic antibiotics for EB-related infections within 7 days before the screening visit (Visit 1).
- Administration of systemic corticosteroids within 30 days (> 10 mg daily of prednisolone or corresponding) or of topical corticosteroids on target wound areas (primary, secondary and reference wound areas) within 14 days before the screening visit (Visit 1). Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.
- Subject has undergone stem cell transplant or gene therapy for the treatment of EB with an effect on target wounds.
- History of malignancy, including basal cell carcinomas or squamous cell carcinomas in the wound areas that will be included in the study.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to TCP-25 or to any excipients of the hydrogel.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.
- Involvement in the planning and/or conduct of the study.
- Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose group 1
0.15 mL of TCP-25 gel (0.86 mg/mL) or 0.15 mL placebo gel per wound applied as topical treatment on days 1, 2, 3, 5, and 8
|
TCP-25 gel (0.86 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient
|
Experimental: Dose group 2
0.15 mL of TCP-25 gel (2.9 mg/mL) or 0.15 mL placebo gel per wound applied as topical treatment on days 1, 2, 3, 5, and 8
|
TCP-25 gel (2.9 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient
|
Experimental: Dose group 3
0.15 mL of TCP-25 gel (8.6 mg/mL) or 0.15 mL placebo gel per wound applied as topical treatment on days 1, 2, 3, 5, and 8
|
TCP-25 gel (8.6 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 15 days in Part I (modified endpoints & timeframes in Part II & III)
|
Frequency, intensity and seriousness of adverse events (AEs)
|
15 days in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions (Local tolerability)
Time Frame: Day 1 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions as compared to expected wound healing outcome, by direct assessment by Investigator:
|
Day 1 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions (Local tolerability)
Time Frame: Day 2 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions as compared to expected wound healing outcome, by direct assessment by Investigator:
|
Day 2 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions (Local tolerability)
Time Frame: Day 3 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions as compared to expected wound healing outcome, by direct assessment by Investigator:
|
Day 3 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions (Local tolerability)
Time Frame: Day 5 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions as compared to expected wound healing outcome, by direct assessment by Investigator:
|
Day 5 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions (Local tolerability)
Time Frame: Day 8 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions as compared to expected wound healing outcome, by direct assessment by Investigator:
|
Day 8 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions (Local tolerability)
Time Frame: Day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions as compared to expected wound healing outcome, by direct assessment by Investigator:
|
Day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions (Local tolerability)
Time Frame: Day 15 in Part I (modified endpoints & timeframes in Part II & III)
|
Incidence of abnormal local reactions as compared to expected wound healing outcome, by direct assessment by Investigator:
|
Day 15 in Part I (modified endpoints & timeframes in Part II & III)
|
Number of patients with clinically significant changes from baseline in electrocardiogram (ECG)
Time Frame: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Systolic and diastolic blood pressure and pulse will be measured.
Any abnormalities will be specified and documented as clinically significant or not clinically significant by the investigator.
|
During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Number of patients with clinically significant changes from baseline in vital signs.
Time Frame: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Vital signs include systolic/diastolic blood pressure and pulse rate.
Any vital signs outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator.
|
During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Number of patients with clinically significant changes from baseline in physical examinations
Time Frame: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
A physical examination will include assessments of general condition, lymph nodes, throat, heart, lungs and abdomen.
Any abnormalities will be specified and documented as clinically significant or not clinically significant by the investigator.
|
During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Number of patients with clinically significant changes from baseline in safety laboratory parameters
Time Frame: During screening (baseline) and on day 2 in Part I (modified endpoints & timeframes in Part II & III)
|
Safety laboratory parameters include haematology, clinical chemistry and coagulation. Any lab values outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator. Haematology parameters to be measured are:
Clinical chemistry parameters to be measured are:
Coagulation parameters to be measured are:
|
During screening (baseline) and on day 2 in Part I (modified endpoints & timeframes in Part II & III)
|
Number of patients with clinically significant changes from baseline in safety laboratory parameters
Time Frame: During screening (baseline) and on day 3 in Part I (modified endpoints & timeframes in Part II & III)
|
Safety laboratory parameters include haematology, clinical chemistry and coagulation. Any lab values outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator. Haematology parameters to be measured are:
Clinical chemistry parameters to be measured are:
Coagulation parameters to be measured are:
|
During screening (baseline) and on day 3 in Part I (modified endpoints & timeframes in Part II & III)
|
Number of patients with clinically significant changes from baseline in safety laboratory parameters
Time Frame: During screening (baseline) and on day 5 in Part I (modified endpoints & timeframes in Part II & III)
|
Safety laboratory parameters include haematology, clinical chemistry and coagulation. Any lab values outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator. Haematology parameters to be measured are:
Clinical chemistry parameters to be measured are:
Coagulation parameters to be measured are:
|
During screening (baseline) and on day 5 in Part I (modified endpoints & timeframes in Part II & III)
|
Number of patients with clinically significant changes from baseline in safety laboratory parameters
Time Frame: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Safety laboratory parameters include haematology, clinical chemistry and coagulation. Any lab values outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator. Haematology parameters to be measured are:
Clinical chemistry parameters to be measured are:
Coagulation parameters to be measured are:
|
During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma concentration of TCP-25
Time Frame: Day 1 (measured before blister formation) in Part I (modified endpoints & timeframes in Part II & III)
|
Measurement of TCP-25 concentration in plasma
|
Day 1 (measured before blister formation) in Part I (modified endpoints & timeframes in Part II & III)
|
Plasma concentration of TCP-25
Time Frame: Day 2 (measured before administration of the intervention and 0.5 and 1 hours after administration of the intervention) in Part I (modified endpoints & timeframes in Part II & III)
|
Measurement of TCP-25 concentration in plasma
|
Day 2 (measured before administration of the intervention and 0.5 and 1 hours after administration of the intervention) in Part I (modified endpoints & timeframes in Part II & III)
|
Plasma concentration of TCP-25
Time Frame: Day 3 (measured before administration of the intervention 1 hour after administration of the intervention) in Part I (modified endpoints & timeframes in Part II & III)
|
Measurement of TCP-25 concentration in plasma
|
Day 3 (measured before administration of the intervention 1 hour after administration of the intervention) in Part I (modified endpoints & timeframes in Part II & III)
|
Plasma concentration of TCP-25
Time Frame: Day 5 (measured before administration of intervention) in Part I (modified endpoints & timeframes in Part II & III)
|
Measurement of TCP-25 concentration in plasma
|
Day 5 (measured before administration of intervention) in Part I (modified endpoints & timeframes in Part II & III)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Congenital Abnormalities
- Skin Ulcer
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Pathological Conditions, Anatomical
- Skin Diseases, Genetic
- Skin Diseases, Vesiculobullous
- Skin Abnormalities
- Varicose Veins
- Collagen Diseases
- Ulcer
- Wounds and Injuries
- Blister
- Leg Ulcer
- Varicose Ulcer
- Epidermolysis Bullosa
- Epidermolysis Bullosa Dystrophica
Other Study ID Numbers
- TCP-25-001
- 2021-004728-14 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blister
-
Stanford UniversityRecruitingBlister of FootChile, Mongolia, Namibia
-
Stanford UniversityResurrection Medical CenterCompletedBlister of FootUnited States
-
Institut de Formation et de Recherche en Médecine...RecruitingSport Injury | Blister of FootFrance
-
Institut de Formation et de Recherche en Médecine...RecruitingSport Injury | Blister of FootFrance
-
Shahid Beheshti University of Medical SciencesUnknownBlebIran, Islamic Republic of
-
Stanford UniversityUniversity of California, DavisCompleted
-
Johnson & Johnson Consumer and Personal Products...Completed
-
Centre Hospitalier Universitaire de NiceRecruiting
-
Aristea Therapeutics, Inc.CompletedInflammatory ResponseUnited Kingdom
-
GlaxoSmithKlineCompletedInflammationUnited Kingdom
Clinical Trials on TCP-25 gel 0.86 mg/ml or placebo gel
-
E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Recruiting
-
Phoenicis TherapeuticsNot yet recruitingDystrophic Epidermolysis BullosaUnited States
-
UroGen Pharma Ltd.CompletedNeoplasms | Urologic Neoplasms | Urologic Diseases | Urinary Bladder Diseases | Urinary Bladder NeoplasmsIndia
-
Fondazione Poliambulanza Istituto OspedalieroCompleted
-
Mayo ClinicCompletedDelirium | DementiaUnited States
-
KGL, Inc.NYU Langone Health; Milton S. Hershey Medical Center; Allergan; State University... and other collaboratorsCompletedAcne VulgarisUnited States
-
Organon and CoCompleted
-
Biolab Sanus FarmaceuticaWithdrawnPost-menopausal Period
-
Clinical Hospital MerkurCompletedInduction of Labor Affected Fetus / Newborn | Prostaglandins Causing Adverse Effects in Therapeutic UseCroatia
-
Al-Azhar UniversityUnknownSkin Diseases | Breast Cancer | Skin CancerEgypt, Saudi Arabia