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 Prevention
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A study in healthy male and female adult volunteers to determine the potential of diacerein 1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing procedure.
This was a randomized, single center, vehicle controlled, within-subject comparison study of diacerein 1% ointment and vehicle ointment applied under fully occlusive patch conditions on the infrascapular region of each subject's back to induce a photoallergic skin reaction following Ultraviolet (UV) irradiation. This was repeated twice each week during the 3-week Induction Phase, once during rest week 4 as applicable and once at Challenge Phase.
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% topical ointment Intra-subject photoallergy (photosensitization) test
Drug: Diacerein 1% ointment
During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
Also known as: CCP-020
Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score
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
Time frame: Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge
| Milestone | Single Cohort (Healthy Volunteers) |
|---|---|
| Started | 61 |
| Diacerein 1% ointment irradiated | 51 |
| Vehicle ointment irradiated | 51 |
| Diacerein 1% ointment non-irradiated | 51 |
| Vehicle ointment non-irradiated | 51 |
| Untreated irradiated | 51 |
| Completed | 51 |
| Not completed | 10 |
| Withdrew: Adverse event | 4 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 5 |
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
| Number of affected skin sites | Single Cohort (Healthy Volunteers) |
|---|---|
| Diacerein irradiated max score 1 at 24 hrs | 10 |
| Diacerein irradiated max score 1 at 48 hrs | 3 |
| Diacerein irradiated max score 1 at 72 hrs | 1 |
| Diacerein non-irradiated max score 1 at 24 hrs | 0 |
| Diacerein non-irradiated max score 1 at 48 hrs | 0 |
| Diacerein non-irradiated max score 1 at 72 hrs | 0 |
| Vehicle irradiated max score 1 at 24 hrs | 10 |
| Vehicle irradiated max score 1 at 48 hrs | 3 |
| Vehicle irradiated max score 1 at 72 hrs | 1 |
| Vehicle non-irradiated max score 1 at 24 hrs | 0 |
| Vehicle non-irradiated max score 1 at 48 hrs | 0 |
| Vehicle non-irradiated max score 1 at 72 hrs | 0 |
| Untreated irradiated max score 1 at 24 hrs | 16 |
| Untreated irradiated max score 1 at 48 hrs | 5 |
| Untreated irradiated max score 1 at 72 hrs | 1 |
Collected over 6 weeks: 3 weeks Induction Period, 2.5 week Rest Period, 0.5 week Challenge Period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Cohort (Healthy Volunteers) | 0/61 (0%) | 0/61 (0%) | 0/61 (0%) |
| Age, Continuous(years) | Single Cohort (Healthy Volunteers) |
|---|---|
| Mean | 52.0 ± 14.46 |
| Sex: Female, Male(Participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| Female | 47 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 54 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 61 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Cohort (Healthy Volunteers) |
|---|---|
| United States | 61 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Mar 2018, 2 months.
Results were first posted in Feb 2020, 1 year 10 months after primary completion.
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Studies of the drug tested here: Diacerein
Castle Creek Pharmaceuticals, LLC