Dermatitis, Phototoxic
Conditions
Brief summary
In this study researchers want to gather information about the potential of Antifungal Cream V61-044 containing Trolamine to produce a phototoxic reaction on the skin. A phototoxic reaction is an irritant reaction of the skin to ultra violet light. In order to find this out the study drug will be applied to the skin of healthy human subjects. By using a solar simulator to generate a UV spectrum similar to that of sunlight the potential of the study drug to produce a superficial reddening of the skin will be measured.
Interventions
Approximately 60 μl of Butenafine HCl 1% applied twice to the treated irradiated site and to the treated non-irradiated site for a total application of 240 μl of Butenafine HCl 1%.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must have been between the ages of 18 and 60 years; * Participants must have been lightly pigmented (Fitzpatrick skin phototypes I, II, III); * Participants must have been in good general health as determined by the subject's medical history; * Participants must have been willing to avoid tanning bed usage and additional sun exposure during the trial and follow-up period; * Participants must have been willing to refrain from using any new topical products during the trial; * Participants must have been able and willing to cooperate with the Investigator and research staff, to have test materials applied according to protocol, and to complete the full course of the trial; * Participants must have been willing to report any medications taken during the trial and refrain from taking any medications during the trial that might produce photoreactions; * If female, participants must produce a negative urine pregnancy test prior to the initiation and also at the completion of the trial.
Exclusion criteria
* Participants must not have had visible sunburn; * Participants must not have had a history of sun hypersensitivity/photosensitivity, or photosensitive dermatoses; * Participants must not have had a history of allergies or sensitivities to cosmetics, toiletries, or any dermatological products; * Participants must not have recently used any systemic or topical drugs which could have caused a photoreaction or may have interfered with the trial; * Participants must not have had any known skin conditions that might interfere with the proper conduct of the trial; * Participants must not have had scars, moles, excessive hair, or other blemishes over the mid or lower back which might have interfered with the test or the grading of the test sites; * Participants must not have had significant history of internal disease that may have interfered with the evaluation of the test material as determined by the Investigator; * Participants must not have been pregnant, planning pregnancy, or nursing a child during the trial period; * Participants must not have used a tanning bed or other artificial tanning lights within the past two months; * Participants must not have participated in a patch test involving the back within four weeks prior to the start of the trial; * Participants must not have concurrently participated in any other clinical or consumer test; * Participants must not have had other conditions considered by the Investigator as sound reasons for disqualification from enrollment into the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation | Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants \*3 time points = 87 sites). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of Erythema on the Treated Non-irradiated Test Sites, Which Would Indicate Irritant Contact Dermatitis and a Pre-existing Allergic Contact Dermatitis | Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation | Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants \*3 time points = 87 sites). |
Countries
United States
Participant flow
Recruitment details
Study was conducted at single center in the US, between 24 JUN 2013 (first subject first visit) and 28 JUN 2013 (last subject last visit).
Pre-assignment details
A total of 32 subjects were enrolled in the study and 29 received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Phototoxicity Reaction Test Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Found to be Ineligible | 3 |
Baseline characteristics
| Characteristic | Phototoxicity Reaction Test |
|---|---|
| Age, Continuous | 40.8 Years STANDARD_DEVIATION 13.6 |
| Race/Ethnicity, Customized Caucasian | 27 Participants |
| Race/Ethnicity, Customized Caucasian/African American | 1 Participants |
| Race/Ethnicity, Customized Caucasian/Hispanic | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score
Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants \*3 time points = 87 sites).
Time frame: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation
Population: Subjects who received treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phototoxicity Reaction Test | Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Treated irradiated test site, score=0 | 77 Test site |
| Phototoxicity Reaction Test | Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Treated irradiated test site, score=1 | 10 Test site |
| Phototoxicity Reaction Test | Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Treated non-irradiated test site, score=0 | 85 Test site |
| Phototoxicity Reaction Test | Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Treated non-irradiated test site, score=1 | 2 Test site |
| Phototoxicity Reaction Test | Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Untreated irradiated test site, score=0 | 78 Test site |
| Phototoxicity Reaction Test | Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Untreated irradiated test site, score=1 | 9 Test site |
| Phototoxicity Reaction Test | Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Untreated non-irradiated test site, score=0 | 85 Test site |
| Phototoxicity Reaction Test | Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score | Untreated non-irradiated test site, score=1 | 2 Test site |
Secondary
Development of Erythema on the Treated Non-irradiated Test Sites, Which Would Indicate Irritant Contact Dermatitis and a Pre-existing Allergic Contact Dermatitis
Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants \*3 time points = 87 sites).
Time frame: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation
Population: Subjects who received treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phototoxicity Reaction Test | Development of Erythema on the Treated Non-irradiated Test Sites, Which Would Indicate Irritant Contact Dermatitis and a Pre-existing Allergic Contact Dermatitis | Treated non-irradiated test site, score=0 | 85 Test site |
| Phototoxicity Reaction Test | Development of Erythema on the Treated Non-irradiated Test Sites, Which Would Indicate Irritant Contact Dermatitis and a Pre-existing Allergic Contact Dermatitis | Treated non-irradiated test site, score=1 | 2 Test site |