HealthyPhase 1NCT03472534

A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment

A Phase 1 study testing diacerein 1% ointment in people with Healthy, run by Castle Creek Pharmaceuticals, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: diacerein 1% ointment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 9 Jan 2018to 30 Jan 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is a healthy male or female (to be confirmed by medical history);
Is 18 years of age or older;
In the case of a female of childbearing potential, is using two acceptable forms of birth control;
In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Who cannot join

Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin, (occasional use of acetaminophen will be permitted);
Is using medication which, in the opinion of the Investigator, will interfere with the study results;
Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
Has psoriasis and/or active atopic dermatitis/eczema;

Show all 11Show fewer

Has a known sensitivity or allergy to constituents of the materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, D\&C Yellow #10 and/or ethyl paraben;
Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
Has received treatment for any type of internal cancer within 5 years prior to study entry;
Has any known sensitivity to adhesives; and/or
Has received any investigational drug(s) within 4 weeks prior to study entry

Trial locations and contacts

1 site in 1 country.

United States1 site

TKL Research
Fair Lawn, New Jersey, 07410

Other trials in United States

About this study

Official title: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design

Read the detailed description

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.

Conditions: Healthy
Being tested: diacerein 1% ointment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

diacerein 1% ointmentDrug
Also called CCP-020
diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.

Study groups in NCT03472534
Study group	Role	What they receive
study in healthy volunteers	Other	diacerein 1% ointment Receives: Drug: diacerein 1% ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Daily for 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 201830 Jan 2018

First posted21 Mar 2018
Study start9 Jan 2018
Primary completion30 Jan 2018
Study completion30 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Cumulative irritancy patch test (CIPT) procedure. All subjects received once daily applications of 0.2mL of diacerein 1% ointment under occlusive patch for 21 days.
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03472534
Sponsor's protocol ID: CCP-020-102
Status last verified: Jan 2020
First submitted: 30 Jan 2018
Last updated: 5 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design
ClinicalTrials.gov ID: NCT03472534
Acronym / sponsor ID: CCP-020-102
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Castle Creek Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Collaborators: TKL Research, Inc.
Study start: 9 Jan 2018 (actual)
Primary completion: 30 Jan 2018 (actual)
Study completion: 30 Jan 2018 (actual)
First posted: 21 Mar 2018 (actual)
Results: Posted 5 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Cumulative irritancy patch test (CIPT) procedure. All subjects received once daily applications of 0.2mL of diacerein 1% ointment under occlusive patch for 21 days.

Arm	Type	Receives
study in healthy volunteers	Other	Drug: diacerein 1% ointmentdiacerein 1% ointment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Is a healthy male or female (to be confirmed by medical history);
Is 18 years of age or older;
In the case of a female of childbearing potential, is using two acceptable forms of birth control;
In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;

Key exclusion criteria (11 listed)

Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin, (occasional use of acetaminophen will be permitted);
Is using medication which, in the opinion of the Investigator, will interfere with the study results;
Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
diacerein 1% ointmentAlso: CCP-020diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.	Drug	study in healthy volunteers

Primary outcome

Skin Irritation Score
Time frame: Daily for 21 days
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.

Results and safety

Results posted to the registry on 5 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Cohort (Healthy Volunteers)	46	35

Primary outcome: Skin Irritation Score

Time frame: Daily for 21 days. Number. Unit: Normalized cumulative irritation score

Measure	Single Cohort (Healthy Volunteers) n = 35
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

Single Cohort (Healthy Volunteers): p <0.0001, Fisher Exact

Population analysed: Per Protocol Population includes all subjects who completed the study with 21 evaluations of irritancy or who discontinued patch sites due to limiting irritation, and was used for analysis of cumulative irritation.

Adverse events

Time frame: Adverse event collection occurred from timing of first dose until completion of last study visit, i.e., 21 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Cohort (Healthy Volunteers)	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Limitations and caveats (from the sponsor): There were no limitations or caveats on this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Spellman, MD study chair

Castle Creek Pharmaceuticals, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing diacerein 1% ointment in people with Healthy, run by Castle Creek Pharmaceuticals, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin Irritation Score (time frame: Daily for 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03472534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.