Healthy
Conditions
Brief summary
This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.
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.
Interventions
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.
Sponsors
Castle Creek Pharmaceuticals, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
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 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 Key
Exclusion criteria
* 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; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Phototoxicity | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Cohort (Healthy Volunteers) 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. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Single Cohort (Healthy Volunteers) |
|---|---|
| Age, Continuous | 55.0 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 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 | 33 Participants |
| Region of Enrollment United States | 34 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
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.
Time frame: Days 3 and 4 (24 and 48 hours post site irradiation procedure)
Population: 5 skin sites on each of 34 participants for a total of 170 skin sites evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Cohort (Healthy Volunteer) | Observed Phototoxicity | Untreated irradiated | 0.15 Score on a scale | Standard Deviation 0.31 |
| Single Cohort (Healthy Volunteer) | Observed Phototoxicity | Diacerein 1% ointment irradiated | 0.15 Score on a scale | Standard Deviation 0.31 |
| Single Cohort (Healthy Volunteer) | Observed Phototoxicity | Vehicle ointment irradiated | 0.15 Score on a scale | Standard Deviation 0.31 |
| Single Cohort (Healthy Volunteer) | Observed Phototoxicity | Diacerein 1% ointment non-irradiated | 0.00 Score on a scale | Standard Deviation 0 |
| Single Cohort (Healthy Volunteer) | Observed Phototoxicity | Vehicle ointment non-irradiated | 0.00 Score on a scale | Standard Deviation 0 |
Comparison: Irradiated vehicle and untreated irradiated sites versus irradiated diacerein site, and non-irradiated vehicle site versus non-irradiated diacerein site and untreated irradiated site versus irradiated vehicle site.p-value: 1ANOVA
Comparison: Non-irradiated diacerein and vehicle sites versus irradiated diacerein site, and irradiated vehicle and untreated irradiated sites versus non-irradiated diacerein site, and non-irradiated vehicle site versus irradiated vehicle site, and untreated irradiated site versus non-irradiated vehicle site.p-value: 0.0008ANOVA