A Phase 1 interventional study of Diacerein 1% ointment in Healthy, sponsored by Castle Creek Pharmaceuticals, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Castle Creek Pharmaceuticals, LLC · Phase 1, Interventional, and Other
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This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.
This was a single-center, randomized, within-subject comparison of diacerein 1% ointment and vehicle ointment applied to 2 sites on opposite sides of the the infrascapular area of the back under occlusive patch conditions for approximately 24 (±2) hours. Product was applied according to the randomization scheme in an amount of 0.2 mL, once during the study.
Patches were removed and 1 of the skin sites for each product was irradiated and 1 remained non-irradiated. The irradiated and non-irradiated sites were compared with each other and with an untreated irradiated control site.
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.
Counted across the registry records on this site, refreshed daily.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Single cohort received diacerein 1% ointment
Drug: Diacerein 1% ointment
Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
Also known as: CCP-020
Observed Phototoxicity
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.
Time frame: Days 3 and 4 (24 and 48 hours post site irradiation procedure)
| Milestone | Single Cohort (Healthy Volunteers) |
|---|---|
| Started | 34 |
| Diacerein 1% ointment irradiated | 34 |
| Vehicle ointment irradiated | 34 |
| Diacerein 1% ointment non-irradiated | 34 |
| Vehicle ointment non-irradiated | 34 |
| Untreated irradiated | 34 |
| Completed | 34 |
| Not completed | 0 |
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.
| Score on a scale | Single Cohort (Healthy Volunteer) |
|---|---|
| Diacerein 1% ointment irradiated | 0.15 ± 0.31 |
| Vehicle ointment irradiated | 0.15 ± 0.31 |
| Diacerein 1% ointment non-irradiated | 0.00 ± 0.00 |
| Vehicle ointment non-irradiated | 0.00 ± 0.00 |
| Untreated irradiated | 0.15 ± 0.31 |
Collected over Adverse Events (AEs) were to be reported from first dose through completion of the last study visit (i.e. Four days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Cohort (Healthy Volunteers) | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(years) | Single Cohort (Healthy Volunteers) |
|---|---|
| Mean | 55.0 (23 to 71) |
| Sex: Female, Male(Participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| Female | 28 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 33 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| United States | 34 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Dec 2017, 0 months.
Results were first posted in Feb 2020, 2 years 1 month after primary completion.
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Studies of the drug tested here: Diacerein
Castle Creek Pharmaceuticals, LLC