Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Castle Creek Pharmaceuticals, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Single Cohort (Healthy Volunteers) |
|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 14.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 61 Participants |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
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
Time frame: Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge
Population: The evaluation of photoallergy was based on all subjects who completed the Challenge Phase of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Diacerein irradiated max score 1 at 24 hrs | 10 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Diacerein irradiated max score 1 at 48 hrs | 3 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Diacerein irradiated max score 1 at 72 hrs | 1 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Diacerein non-irradiated max score 1 at 24 hrs | 0 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Diacerein non-irradiated max score 1 at 48 hrs | 0 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Diacerein non-irradiated max score 1 at 72 hrs | 0 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Vehicle irradiated max score 1 at 24 hrs | 10 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Vehicle irradiated max score 1 at 48 hrs | 3 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Vehicle irradiated max score 1 at 72 hrs | 1 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Vehicle non-irradiated max score 1 at 24 hrs | 0 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Vehicle non-irradiated max score 1 at 48 hrs | 0 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Vehicle non-irradiated max score 1 at 72 hrs | 0 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Untreated irradiated max score 1 at 24 hrs | 16 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Untreated irradiated max score 1 at 48 hrs | 5 Number of affected skin sites |
| Single Cohort (Healthy Volunteers) | Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score | Untreated irradiated max score 1 at 72 hrs | 1 Number of affected skin sites |