Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
diacerein 1% · 6 trials · 6 indications
Number and percentage of participants with any treatment-emergent adverse event.
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.
The determination of dermal sensitization potential was based on the recurrence of a cutaneous response at re-challenge that was equivalent or more severe than the cumulative irritation score observed during the challenge period. Cumulative irritation score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome.
Evaluation of the sum of all subjects' cumulative irritation scores for 21 days at each patch site. Cumulative Irritation Score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome.
The determination of photosensitization reactions was summarized by frequency counts of the total dermal irritation score during the Challenge Phase. Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score=0, maximum score=5; higher score=worse outcome
The mean of the total irritation scores 24 and 48 hours post the site irradiation procedure. ( i.e. Day 3 and 4) Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score= 0; Maximum score = 5; higher score = worse outcome.
| Arm | Type | Description |
|---|---|---|
| Treatment period | EXPERIMENTAL | 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. |
| Cohort 1 (Adolescents, Adults) | EXPERIMENTAL | Adolescent and adult subjects with EB (aged 12 years and older) received diacerein 1% ointment daily for 10 days. |
| Cohort 2 (Children) | EXPERIMENTAL | Children with EB (aged 4 to 11 years, inclusive) received diacerein 1% ointment daily for 10 days. |
| Single cohort (Healthy Volunteers) | EXPERIMENTAL | diacerein 1% ointment |
| study in healthy volunteers | OTHER | diacerein 1% ointment |
| Name | Type | Description |
|---|---|---|
| diacerein 1% ointment | DRUG | Topically apply study medication to lesions identified by the Investigator that require. treatment |
Key Inclusion Criteria: * The subject is capable of understanding and complying with protocol requirements. * The subject or the subject's legally acceptable representative signs and dates a written, informed consent/assent form and any required privacy authorization prior to the initiation of any ...
Diacerein 1% is an investigational topical ointment being studied for the treatment of Epidermolysis Bullosa (EB), a rare genetic skin disorder. It is also used in clinical trials involving healthy subjects to evaluate its safety profile, including skin sensitization, phototoxicity, and photoallergic potential.
Diacerein 1% is being developed by Castle Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CSTL. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with Epidermolysis Bullosa.
Diacerein 1% is in Phase 1 clinical development. All four clinical trials associated with the drug are Phase 1 studies, and all have been completed. The drug is investigational and has not been approved by regulatory authorities for any indication.
Diacerein 1% has been studied in four completed Phase 1 clinical trials: NCT03472287 (pharmacokinetics in EB patients), NCT03472547 (skin sensitization in healthy subjects), NCT03473184 (phototoxicity in healthy volunteers), and NCT03473197 (photoallergic potential in healthy volunteers).
Diacerein 1% is a small molecule that works by inhibiting the activity of interleukin-1 beta (IL-1β), a pro-inflammatory cytokine involved in the blistering and inflammation seen in Epidermolysis Bullosa. By reducing IL-1β activity, the drug aims to decrease skin inflammation and blister formation.
Diacerein 1% is a topical formulation of diacerein, a compound that has been used orally for osteoarthritis in some countries. In this context, diacerein is formulated as a 1% ointment for topical application to treat Epidermolysis Bullosa, a different indication and route of administration.