A Phase 1 interventional study of Diacerein 1% Ointment in Epidermolysis Bullosa (EB), Epidermolysis Bullosa Simplex and Dystrophic Epidermolysis Bullosa, sponsored by Castle Creek Pharmaceuticals, LLC. Completed at 3 sites in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Castle Creek Pharmaceuticals, LLC · Phase 1, Interventional, and Other
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Among 41 studies in Epidermolysis Bullosa with a site in United States — 9 open to participants now, 12 under way, 3 of them phase 3. Epidermolysis Bullosa · United States.
Among the 41 studies in Epidermolysis Bullosa with a site in United States, this one is the 23rd largest by enrollment of the 36 interventional ones that give a count, is the only one that started in 2018, is one of 7 in phase 1, and was the 20th registered.
85 studies on the registry are indexed under Epidermolysis Bullosa; 17 are open to participants now.
Browse Epidermolysis Bullosa studies →9 of the 41 studies in Epidermolysis Bullosa with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 5–21
Paradigm Therapeutics · Sites in United States
Ages 28 days–12 yrs
Xinnate AB · Sites in United States, France, Greece and 4 more countries
Ages 4+
BioMendics, LLC · Sites in United States
Ages 2+
M. Peter Marinkovich · Sites in United States
Ages 6+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Epidermolysis Bullosa studies recruiting now, 9 (82%) set no upper age limit and 2 (18%) stop at 75 or younger; 10 take children under 18; 1 takes healthy volunteers.
This study: 4 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 17 · Phase 3 8
First in 2007; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 11 is below the median of 14 across 67 interventional studies indexed under Epidermolysis Bullosa.
Median enrollment 16 across the 36 interventional studies, 60 across the 5 observational. Of the 26 that completed or were terminated, 16 (62%) have results posted.
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21 of 41 have an industry lead sponsor. The 10 most frequent:
Castle Creek Pharmaceuticals, LLC is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Castle Creek Pharmaceuticals, LLC has 2 studies filed under Epidermolysis Bullosa — fewer than ten, so there is no comparison to draw.
6 of the studies in Epidermolysis Bullosa with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07482787Phase 3Paradigm TherapeuticsEfficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa | 2027-05-17 |
| NCT07027345BioMendics, LLCA Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex | 2027-01 |
| NCT06834035M. Peter MarinkovichTargeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa | 2027-03 |
| NCT07050810Northwestern UniversityThera-Clean® Microbubbles System in Patients With Skin Diseases | 2027-06 |
| NCT06594393Xinnate ABA Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study | 2027-06-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 41 studies in Epidermolysis Bullosa with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive). Cohort 2 only included subjects 4 yrs and older. Serial PK blood sampling collected on Days 1 and 10. Analyses were performed to determine the concentrations of diacerein and rhein.
This was an open-label, single-period study that intended to include subjects with EB consisting of infants/ children (ages 6 months to 11 years, inclusive) and adolescents/ adults (ages 12 years and older). The study included 2 cohorts.
Cohort 1 was to include adolescent/adult subjects with EB (ages 12 years and older);
Cohort 2 was to include infants/children with EB (ages 4 to 11 years, inclusive).
For both cohorts, the study intended to enroll subjects with epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), and junctional epidermolysis bullosa (JEB) with lesions encompassing >/=2% BSA. The diacerein application area was >/=5% BSA and included lesioned and non-lesioned skin (if lesions accounted for \<5% BSA); however, topical administration was \</=30% BSA. On Days 1 and 10, the topical dose of study drug was applied by study staff, and blood was sampled for PK analyses of diacerein and rhein pre-dose and through 8 hours post-application. On Days 2 to 9, study drug was applied to the application area(s) at home. For Cohort 1, trough PK samples were collected on any 2 available days from Days 3 through 9, and study drug was applied after blood draw, while for Cohort 2 trough PK analyses were not performed.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adolescent and adult subjects with EB (aged 12 years and older) received diacerein 1% ointment daily for 10 days.
Drug: Diacerein 1% Ointment
Children with EB (aged 4 to 11 years, inclusive) received diacerein 1% ointment daily for 10 days.
Drug: Diacerein 1% Ointment
Diacerein 1% Ointment administered topically
Also known as: CCP-020
Detectable Plasma Concentrations of Diacerein and Rhein
Bioanalytical analyses were performed to determine concentrations levels of diacerein and rhein in plasma using validated bioanalytical methods. For Cohort 1, blood samples were taken at pre-dose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. For Cohort 2, blood samples were taken at pre-dose and 1, 2, 4, 6, and 8 hours post-dose. Trough PK samples were collected on any 2 available days from Days 3 through 9 for Cohort 1 only. Summary statistics for each scheduled time were only reported if at least 50% of subjects had quantifiable concentrations.
Time frame: Days 1-10, at select time points per protocol
| Milestone | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) |
|---|---|---|
| Started | 8 | 3 |
| Completed | 8 | 3 |
| Not completed | 0 | 0 |
Bioanalytical analyses were performed to determine concentrations levels of diacerein and rhein in plasma using validated bioanalytical methods. For Cohort 1, blood samples were taken at pre-dose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. For Cohort 2, blood samples were taken at pre-dose and 1, 2, 4, 6, and 8 hours post-dose. Trough PK samples were collected on any 2 available days from Days 3 through 9 for Cohort 1 only. Summary statistics for each scheduled time were only reported if at least 50% of subjects had quantifiable concentrations.
| Participants | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) |
|---|---|---|
| Rhein Below the limit of quantification:EBS | 3 | 2 |
| Rhein Below the limit of quantification:DEB | 0 | 0 |
| Rhein Above Lower limit of quantification:EBS | 1 | 1 |
| Rhein Above Lower limit of quantification:DEB | 4 | 0 |
| Diacerein Below the limit of quantification:EBS | 4 | 3 |
| Diacerein Below the limit of quantification:DEB | 4 | 0 |
| Diacerein Above Lower limit of quantification:EBS | 0 | 0 |
| Diacerein Above Lower limit of quantification:DEB | 0 | 0 |
Collected over Baseline to 30 days after last dose of study drug application (40 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 (Adolescents, Adults) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Cohort 2 (Children) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Event | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) |
|---|---|---|
| PyrexiaGeneral disorders | 1/8 | 0/3 |
| Age, Continuous(years) | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) | Total |
|---|---|---|---|
| Mean | 26.5 ± 11.74 | 8.3 ± 1.53 | 21.5 ± 13.0 |
| Sex: Female, Male(Participants) | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 3 | 2 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 7 | 1 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 7 | 2 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) | Total |
|---|---|---|---|
| United States | 8 | 3 | 11 |
| EB Classification per Cohort(participants) | Cohort 1 (Adolescents, Adults) | Cohort 2 (Children) | Total |
|---|---|---|---|
| Epidermolysis Bullosa Simplex (EBS) | 4 | 3 | 7 |
| Dystrophic Epidermolysis Bullosa (DEB) | 4 | 0 | 4 |
| Junctional Epidermolysis Bullosa (JEB) | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Jan 2019, 8 months.
Results were first posted in Feb 2020, 1 year after primary completion.
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Studies of the drug tested here: Diacerein
Castle Creek Pharmaceuticals, LLC