HealthyPhase 1NCT03473184

A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers

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

This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure. 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: 34 participants
Where: 1 siteUnited States
Study dates: 12 Dec 2017to 15 Dec 2017
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) at Day 1 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 adverse events (AEs);
Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Who cannot join

Has a history of photosensitivity or photoallergy;
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 taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs [NSAIDs]);
Has psoriasis and/or active atopic dermatitis/eczema;

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Has known sensitivity or allergy to constituents of 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 4 Day, Randomized Study to Evaluate the Potential of CCP-020 (Diacerein 1%) Topical Ointment to Induce a Phototoxicity Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test

This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.

Read the detailed description

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.

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 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.

Study groups in NCT03473184
Study group	Role	What they receive
Single Cohort (Healthy Volunteers)	Experimental	Single cohort received 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.

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.
Measured: Days 3 and 4 (24 and 48 hours post site irradiation procedure)

Timeline

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

12 Dec 201715 Dec 2017

First posted22 Mar 2018
Study start12 Dec 2017
Primary completion15 Dec 2017
Study completion15 Dec 2017

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: Phototoxicity Potential Assessment (Photopatch test). All subjects received applications of 0.2 mL of diacerein 1% ointment and vehicle ointment under occlusive patch conditions to 2 skin sites at the infrascapular area of the back for approximately 24 (±2) hours. Following the removal of the patches, one site was irradiated and one remained non-irradiated.
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03473184
Sponsor's protocol ID: CCP-020-104
Status last verified: Feb 2020
First submitted: 5 Mar 2018
Last updated: 10 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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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4 Day, Randomized Study to Evaluate the Potential of CCP-020 (Diacerein 1%) Topical Ointment to Induce a Phototoxicity Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test
ClinicalTrials.gov ID: NCT03473184
Acronym / sponsor ID: CCP-020-104
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Castle Creek Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Study start: 12 Dec 2017 (actual)
Primary completion: 15 Dec 2017 (actual)
Study completion: 15 Dec 2017 (actual)
First posted: 22 Mar 2018 (actual)
Results: Posted 10 Feb 2020

Clinical summary

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

This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Phototoxicity Potential Assessment (Photopatch test). All subjects received applications of 0.2 mL of diacerein 1% ointment and vehicle ointment under occlusive patch conditions to 2 skin sites at the infrascapular area of the back for approximately 24 (±2) hours. Following the removal of the patches, one site was irradiated and one remained non-irradiated.

Arm	Type	Receives
Single Cohort (Healthy Volunteers)	Experimental	Drug: Diacerein 1% ointmentSingle cohort received diacerein 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) at Day 1 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 adverse events (AEs);

Key exclusion criteria (11 listed)

Has a history of photosensitivity or photoallergy;
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 taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs [NSAIDs]);

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 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.	Drug	Single Cohort (Healthy Volunteers)

Primary outcome

Observed Phototoxicity
Time frame: Days 3 and 4 (24 and 48 hours post site irradiation procedure)
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.

Results and safety

Results posted to the registry on 10 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)	34	34

Primary outcome: Observed Phototoxicity

Time frame: Days 3 and 4 (24 and 48 hours post site irradiation procedure). Mean (Standard Deviation). Unit: Score on a scale

Measure	Single Cohort (Healthy Volunteer) n = 34
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)

Single Cohort (Healthy Volunteer): p = 1.0000, ANOVA
Single Cohort (Healthy Volunteer): p = 0.0008, ANOVA

Population analysed: 5 skin sites on each of 34 participants for a total of 170 skin sites evaluated.

Adverse events

Time frame: Adverse Events (AEs) were to be reported from first dose through completion of the last study visit (i.e. Four days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Cohort (Healthy Volunteers)	0 of 34 (0%)	0 of 34 (0%)	0 of 34

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 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 10 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 10 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?

Observed Phototoxicity (time frame: Days 3 and 4 (24 and 48 hours post site irradiation procedure)). 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 NCT03473184.

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 10 Feb 2020.