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 2020-02-05.
Sponsored by Castle Creek Pharmaceuticals, LLC · Phase 1, Interventional, and Other
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Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the irritation potential of diacerein1% ointment on normal skin of healthy volunteers, using a cumulative irritancy patch test (CIPT) procedure.
This study was designed to assess the cumulative irritation potential of diacerein 1% ointment in comparison with vehicle ointment, 0.2% sodium lauryl sulfate (SLS) (positive control), and 0.9% saline (negative control) on normal skin of healthy volunteers using a cumulative irritancy patch test (CIPT) procedure applied once daily for 21 days.
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.
diacerein 1% ointment
Drug: diacerein 1% ointment
diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.
Also known as: CCP-020
Skin Irritation Score
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.
Time frame: Daily for 21 days
| Milestone | Single Cohort (Healthy Volunteers) |
|---|---|
| Started | 46 |
| Diacerein 1% ointment | 46 |
| Vehicle ointment | 46 |
| 0.2% sodium lauryl sulfate (sls) | 46 |
| 0.9% saline | 46 |
| Completed | 35 |
| Not completed | 11 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Adverse event | 2 |
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.
| Normalized cumulative irritation score | Single Cohort (Healthy Volunteers) |
|---|---|
| Diacerein 1% ointment | 0 |
| Vehicle 1% ointment | 0 |
| 0.2% sodium lauryl sulfate (SLS) (positive control | 339 |
| 0.9% saline (negative control)" Arms/Groups) | 15 |
Collected over Adverse event collection occurred from timing of first dose until completion of last study visit, i.e., 21 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Cohort (Healthy Volunteers) | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(years) | Single Cohort (Healthy Volunteers) |
|---|---|
| Mean | 53 ± 13 |
| Sex: Female, Male(Participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| Female | 34 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| Count of Participants — American Indian or Alaska Native | 0 |
| Count of Participants — Asian | 1 |
| Count of Participants — Native Hawaiian or Other Pacific Islander | 0 |
| Count of Participants — Black or African American | 27 |
| Count of Participants — White | 18 |
| Count of Participants — More than one race | 0 |
| Count of Participants — Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| United States | 46 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Jan 2018, 0 months.
Results were first posted in Feb 2020, 2 years after primary completion.
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diacerein
Castle Creek Pharmaceuticals, LLC