The Unit for Laboratory Animal Medicine (ULAM) is now enrolling participants from the U-M research community in a new clinical trial involving mice with ulcerative dermatitis (UD), a common disorder that manifests as ulceration and inflammation of the skin.
This study is specifically focused on mice who present with “Classic” UD (see first accordion below), and will evaluate the efficacy of a novel topical treatment called ZoSil-DN, a medication that contains Diphenhydramine HCL and Naltrexone HCL.
Animals participating in the trial can continue on-study as described in your laboratory’s existing IACUC approved protocol with no restrictions or interruption of scheduled experiments. The trial will last for approximately 28 days, and laboratories may opt out a given animal, or all animals, at any time and for any reason.
Outside of the standard re-check fees associated with treating mice with UD, there is no cost to participate. Laboratories who enroll in the trial will be provided with the topical ZoSil-DN medication and nail trims free-of-charge.
How to Enroll
- For logistical efficiency, the ULAM Study Team is only enrolling laboratories at the North Campus Research Complex at this time. The trial will extend to additional animal housing locations later in the fall.
- If you have a high rate of UD in your colony and are interested in enrolling, contact the ULAM Study Team at [email protected]. The Study Team may also contact your laboratory as candidate animals are identified during routine clinical care.
- Veterinary staff will evaluate animals with lesions to confirm they meet inclusion criteria based on the ULAM veterinary guidelines for ulcerative dermatitis.
- If the animal meets inclusion criteria, your laboratory will be contacted to confirm approval prior to treatment being initiated.
Additional Information
Ulcerative Dermatitis (UD) is a common disorder affecting mice that manifests as ulceration and inflammation of the skin. UD is associated with pruritus (itching) which causes mice to scratch, often leading to secondary infection, skin damage, and worsening lesions.
The disorder is frequently seen in mice with a C57BL/6 background but can occur in any mouse. Aged female animals and mice on high-fat diets are also known to be at increased risk for the development of UD.
Types of UD:
There are two types of UD, differentiated by lesion location and character:
- “Classic” UD – Lesions at the nape, dorsum, and shoulders; often associated with erythema and crusting. These animals are pruritic.
- “Atypical” or “Flank” UD – Lesions at the flanks, dorsum, and hind limbs. These animals are usually NOT pruritic.
This study is specifically focused on animals with “classic” lesions.
There are currently no definitive therapies for UD in mice, and disease management is limited to weekly nail trims to minimize self-trauma. Despite these treatments, lesions often progress and ultimately require the animal to be humanely euthanized.
ZoSil-DN is a topical medication that contains Diphenhydramine HCL and Naltrexone HCL. The product may reduce pruritus in “Classic” UD, leading to less scratch-induced secondary trauma, which allows the affected area to heal.
Systemic absorption is unlikely yet remains possible via absorption through the skin or ingestion as mice groom.
Initial pilot data collected at U-M has shown rapid resolution of UD lesions and reductions in scratching behavior when ZoSil-DN has been applied.
With laboratory approval, the identified candidate animal(s) will be randomized into ONE of THREE treatment groups:
Only Nail Trims – According to published literature, nail trims are considered the primary treatment for UD.
Only ZoSil-DN – The topical application must be completed once daily. Laboratories will be responsible for application; ULAM will provide the product and proper training for application to the animal free-of-charge.
ZoSil-DN and Nail Trims – Animals will receive both topical application of ZoSil-DN and routine nail trims (see additional details below).
Instructions for Nail Trims
For animals in the relevant treatment groups (e.g., Groups 1 and 3 above), nail trims will be completed once every 1-2 weeks depending on nail growth rate.
Nail trims will be performed by ULAM veterinary staff as part of routine clinical care, with no additional charges outside of the standard re-check fees associated with treating mice with UD.
Consistent with standard ULAM veterinary care procedures, veterinary staff will continue to monitor all animals closely and will contact the laboratory should additional treatment or humane euthanasia be required based on lesion progression.
Once initiated, the trial will last for approximately 28 days. Laboratories may opt out a given animal, or all animals, at any time and for any reason.
The ULAM Study Team, in close consultation with participating laboratories, may remove animals earlier if any of the following conditions are met:
- Lesions and/or pruritus are significantly reduced or resolved
- Lesions and/or pruritus significantly worsen within two weeks of treatment
- Standard or study-related end-stage criteria (whether related to UD or not) has been met
- Protocol-specific endpoints have been reached
Please note: Any laboratory who humanely euthanizes an animal being treated as part of this clinical trial must inform the ULAM Study Team of the euthanasia date and the reason animals were removed from the study.
Questions?
Questions about this study should be directed to the ULAM Study Team at [email protected].
Thank you for considering participation in this new clinical trial to help enhance animal welfare at the U-M and within the field of laboratory animal medicine.