Healthy
Conditions
Brief 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.
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.
Interventions
diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.
Sponsors
TKL Research, Inc.
Castle Creek Pharmaceuticals, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
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) 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 Key
Exclusion criteria
* 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; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Irritation Score | 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. |
Countries
United States
Participant flow
Pre-assignment details
This does not apply
Participants by arm
| Arm | Count |
|---|---|
| Single Cohort (Healthy Volunteers) Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Single Cohort (Healthy Volunteers) |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) Count of Participants American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Count of Participants Asian | 1 Participants |
| Race (NIH/OMB) Count of Participants Black or African American | 27 Participants |
| Race (NIH/OMB) Count of Participants More than one race | 0 Participants |
| Race (NIH/OMB) Count of Participants Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Count of Participants Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Count of Participants White | 18 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
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.
Time frame: Daily for 21 days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Cohort (Healthy Volunteers) | Skin Irritation Score | Vehicle 1% ointment | 0 Normalized cumulative irritation score |
| Single Cohort (Healthy Volunteers) | Skin Irritation Score | 0.2% sodium lauryl sulfate (SLS) (positive control | 339 Normalized cumulative irritation score |
| Single Cohort (Healthy Volunteers) | Skin Irritation Score | Diacerein 1% ointment | 0 Normalized cumulative irritation score |
| Single Cohort (Healthy Volunteers) | Skin Irritation Score | 0.9% saline (negative control) Arms/Groups) | 15 Normalized cumulative irritation score |
p-value: <0.0001Fisher Exact