A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/10/2017 |
| Start Date: | February 2016 |
| End Date: | June 2016 |
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of LEO 43204 Gel and Gel Vehicle in Healthy Volunteers Using a Repeat Insult Patch Test Design
This is a randomized, single-center, controlled, within-subject comparison study assessing
the sensitization potential of the investigational product, LEO 43204 gel under open
conditions in healthy volunteers.
LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of
the back. Evaluation of dermal reactions at the application sites will be assessed
clinically using a visual scale that rates the degree of erythema, edema and other signs of
cutaneous irritation.
Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will
enter the Challenge Phase, which consists of one 48-hour application to a naive site on the
opposite side of the back. Observations at the naive site during Challenge and the patterns
of reactivity during the Induction Phase will provide a basis for an interpretation of
contact sensitization.
A total of 10 applications will be made over a period of approximately 6-8 weeks.
the sensitization potential of the investigational product, LEO 43204 gel under open
conditions in healthy volunteers.
LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of
the back. Evaluation of dermal reactions at the application sites will be assessed
clinically using a visual scale that rates the degree of erythema, edema and other signs of
cutaneous irritation.
Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will
enter the Challenge Phase, which consists of one 48-hour application to a naive site on the
opposite side of the back. Observations at the naive site during Challenge and the patterns
of reactivity during the Induction Phase will provide a basis for an interpretation of
contact sensitization.
A total of 10 applications will be made over a period of approximately 6-8 weeks.
Inclusion Criteria:
1. Are free of any systemic or dermatologic disorder, which, in the opinion of the
investigator, will interfere with the study results or increase the risk of adverse
events;
2. Fitzpatrick skin types I-IV (due to lack of safety data for the investigational
product in darker skin types);
3. Complete a Medical Screening form as well as a Medical Personal History form;
Exclusion Criteria:
1. Have any visible skin disease at the application site which, in the opinion of the
investigative personnel, will interfere with the evaluation of the test site
reaction;
2. Are not willing to refrain from using topical/systemic analgesics for 72 hours prior
to and during the study (daily use of 81 mg aspirin is acceptable and occasional use
of acetaminophen will be permitted);
3. Are using systemic/topical corticosteroids for 3 weeks prior to and during the study,
or systemic/topical antihistamines for 72 hours prior to and during the study;
4. Are using medication which, in the opinion of the investigative personnel, will
interfere with the study results, including anti-inflammatory medications;
5. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams,
ointments, lotions, or similar products on the back during the study;
6. Have psoriasis and/or active atopic dermatitis/eczema;
7. Have 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;
We found this trial at
1
site
Click here to add this to my saved trials
