A Phase 2 interventional study of diacerein 1% ointment in Epidermolysis Bullosa and Epidermolysis Bullosa Simplex, sponsored by Castle Creek Pharmaceuticals, LLC. Completed at 3 sites in United States. Open to participants aged 6 Months to 99 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Castle Creek Pharmaceuticals, LLC · Phase 2, Interventional, and Treatment
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Among 11 studies in Epidermolysis Bullosa Simplex with a site in United States — 3 open to participants now, 4 under way, 1 of them phase 3. Epidermolysis Bullosa Simplex · United States.
Among the 11 studies in Epidermolysis Bullosa Simplex with a site in United States, this one is one of 3 that started in 2017, is one of 5 in phase 2, and was the 5th registered.
20 studies on the registry are indexed under Epidermolysis Bullosa Simplex; 5 are open to participants now.
Browse Epidermolysis Bullosa Simplex studies →3 of the 11 studies in Epidermolysis Bullosa Simplex with a site in United States are open now. Recruiting first, the newest first:
BioMendics, LLC · Sites in United States
Ages 2+
Joyce Teng · Sites in United States
Ages 0+ · Healthy volunteers
Stanford University · Sites in United States
Ages 6 mo+
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 4 Epidermolysis Bullosa Simplex studies recruiting now, 3 set no upper age limit and none stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 6 Months to 99 Years · 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.
11 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 3 · Phase 2 6 · Phase 3 1
First in 2015; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 51 is above the median of 19 across 17 interventional studies indexed under Epidermolysis Bullosa Simplex.
Median enrollment 11 across the 9 interventional studies, 30 across the 2 observational. Of the 6 that completed or were terminated, 4 (67%) have results posted.
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6 of 11 have an industry lead sponsor. The 7 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 3 studies filed under Epidermolysis Bullosa Simplex — fewer than ten, so there is no comparison to draw.
2 of the studies in Epidermolysis Bullosa Simplex with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07027345BioMendics, LLCA Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex | 2027-01 |
| NCT07756138Stanford UniversityFilsuvez in Moderate-to-Severe Epidermolysis Bullosa Simplex | 2027-01-15 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies in Epidermolysis Bullosa Simplex with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to evaluate the long term safety and tolerability of diacerein 1% ointment for 2 treatment cycles in subjects with EBS that previously participated in the CCP-020-301 or the CCP-020-101 studies.
This is an international, multicenter, open-label, long term extension study evaluating the safety of topical Diacerein 1% Ointment for the treatment of subjects with EBS. At Visit 1, EBS subjects who completed the CCP-020-301 double-blind safety and efficacy study or participated in the CCP-020-101 PK study (feeder studies) who meet all the inclusion/exclusion criteria will be eligible to complete 2 treatment cycles of CCP-020.
Each treatment cycle will consist of 8 weeks on treatment (once-daily, at home study medication applications) followed by 8 weeks off treatment (only Investigator approved bland, non-medicated emollient/moisturizer, routine cleansing products and sunscreens) with a maximum of 2 treatment cycles allowed for up to 52 weeks.
At Baseline Visit (corresponding to the final study visit of the feeder study), the investigator will perform a clinical assessment and determine if any of the subject's lesions require treatment (up to 30% BSA). If the subject has active lesions as determined by the Investigator's clinical assessment, the subject will initiate a cycle of once-daily, at home study medication application to their EBS lesions for 8 weeks (treatment period) followed by an 8-week period where no treatment will be administered. Subjects presenting with no active lesions (as determined by the Investigator's clinical assessment) will not begin treatment and instead, will be instructed to return to the clinic for re-evaluation in 8 weeks or upon worsening of EBS lesions, whichever happens first.
20 studies on the registry are indexed under Epidermolysis Bullosa Simplex; 5 are open to participants now.
This study's enrollment of 51 is above the median of 19 across 17 interventional studies indexed under Epidermolysis Bullosa Simplex.
Browse Epidermolysis Bullosa Simplex studies →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.
Compared within Epidermolysis Bullosa Simplex, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epidermolysis Bullosa. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with active lesions as determined Investigator's clinical assessment, will initiate a cycle of applying diacerein 1% ointment once-daily, study medication, at home to their EBS lesions for 8 weeks. Following the Treatment Period, subjects will go Off Treatment for 8 weeks using only investigator approved bland, non-medicated emollient/moisturizer, routine cleansing products and sunscreens. As determined Investigator's clinical assessment, subjects may enter into another Treatment Period of 8 weeks. The duration of a subject's participation in the extension study may be as short as 32 weeks or as long as 52 weeks depending on the cycle initiation schedule for each individual subject.
Drug: diacerein 1% ointment
Topically apply study medication to lesions identified by the Investigator that require. treatment
Also known as: CCP-020
Treatment-emergent Adverse Events
Number and percentage of participants with any treatment-emergent adverse event.
Time frame: up to 52 weeks
| Milestone | Diacerein 1% Ointment |
|---|---|
| Started | 51 |
| Completed | 39 |
| Not completed | 12 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Adverse event | 2 |
| Withdrew: Sponsor request | 2 |
Number and percentage of participants with any treatment-emergent adverse event.
| Participants | Diacerein 1% Ointment |
|---|---|
| Treatment-emergent Adverse Events | 40 |
Collected over Up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diacerein 1% Ointment | 0/51 (0%) | 0/51 (0%) | 21/51 (41.2%) |
| Event | Diacerein 1% Ointment |
|---|---|
| NasopharyngitisInfections and infestations | 7/51 |
| Skin infectionInfections and infestations | 5/51 |
| PyrexiaGeneral disorders | 4/51 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/51 |
| PruritusSkin and subcutaneous tissue disorders | 4/51 |
| Ear infectionInfections and infestations | 3/51 |
| Gastroenteritis viralInfections and infestations | 3/51 |
| Age, Categorical(Participants) | Diacerein 1% Ointment |
|---|---|
| <=18 years | 40 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Age, Continuous(years) | Diacerein 1% Ointment |
|---|---|
| Mean | 12.6 ± 10.70 |
| Sex: Female, Male(Participants) | Diacerein 1% Ointment |
|---|---|
| Female | 26 |
| Male | 25 |
| Race and Ethnicity Not Collected(Participants) | Diacerein 1% Ointment |
|---|
| Region of Enrollment(Participants) | Diacerein 1% Ointment |
|---|---|
| Austria | 1 |
| Israel | 5 |
| Australia | 2 |
| United Kingdom | 7 |
| Netherlands | 3 |
| France | 9 |
| Germany | 2 |
| United States | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Apr 2020, 28 months.
Results were first posted in Sep 2020, 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diacerein
Epidermolysis Bullosa Simplex →
Castle Creek Pharmaceuticals, LLC