Study Completed

Dermatitis, Phototoxic

Bayer Identifier:

18154

ClinicalTrials.gov Identifier:

NCT04531527

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study to learn more about the potential of Antifungal Cream V61-044 containing Trolamine to cause irritant reaction of the skin to ultra violet light in healthy human subjects

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 60 Years

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.

Trial summary

Enrollment Goal

Trial Dates

June 2013 - June 2013

Phase

Phase 3

Could I Receive a placebo

Products

LOTRIMIN ULTRA (Butenafine HCl, BAY1896425)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Fairfield, 07004, United States

Primary Outcome

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.
Time Frame:
4 days

Secondary Outcome

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.
Time Frame:
4 days

Trial design

HT201308- Human Phototoxicity Test

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

N/A

Assignment

Single Group Assignment

Trial Arms

Additional Information

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