A 6-Week Study to Evaluate the Photoallergic Potential of... | NCT03473197

NCT03473197

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Single Cohort (Healthy Volunteers)	Other	Diacerein 1% topical ointment Intra-subject photoallergy (photosensitization) test	Drug: Diacerein 1% ointment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diacerein 1% ointment	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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 an acceptable form 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 AEs;
Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Key Exclusion Criteria:

Has a history of photosensitivity or photoallergy;
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);
Are taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs [NSAIDS]);
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;
Had 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 drugs(s) with 4 weeks prior to study entry

Name	Affiliation	Role
Mary Spellman, MD	Castle Creek Pharmaceuticals, LLC	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
TKL Research		Fair Lawn	New Jersey	07410	United States

Arm/Group Information

ID	Title	Description
FG000	Single Cohort (Healthy Volunteers)	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00061 subjects255 units
Diacerein 1% Ointment Irradiated		FG00051 subjects51 units
Vehicle Ointment Irradiated		FG00051 subjects51 units
Diacerein 1% Ointment Non-irradiated		FG00051 subjects51 units
Vehicle Ointment Non-irradiated		FG00051 subjects51 units
Untreated Irradiated		FG00051 subjects51 units
COMPLETED		FG00051 subjects255 units
NOT COMPLETED		FG00010 subjects0 units

Type	Comment	Reasons
Adverse Event		FG0004 subjects
Lost to Follow-up		FG0001 subjects
Withdrawal by Subject		FG0005 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Single Cohort (Healthy Volunteers)	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

The evaluation of photoallergy was based on all subjects who completed the Challenge Phase of the study.

Posted

Number

Number of affected skin sites

Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge

skin sites

ID	Title	Description
OG000	Single Cohort (Healthy Volunteers)	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Single Cohort (Healthy Volunteers)	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.

ID	Term
C025292	diacerein
D009824	Ointments

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations