Novel Compositions for Treating or Preventing Dermal Disorders
|ClinicalTrials.gov Identifier: NCT03103893|
Recruitment Status : Unknown
Verified October 2017 by Drexel University.
Recruitment status was: Recruiting
First Posted : April 6, 2017
Last Update Posted : October 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dermal Atrophy||Drug: Rapamycin||Phase 1 Phase 2|
Aging of the skin is the most prominent feature of the aging process, being caused by multiple factors such as intrinsic aging process and UV light exposure.
Dermal atrophy, also called skin atrophy or atrophy, is a disorder manifesting thinning or depression of skin due to reduction of underlying tissue. Dermal atrophy is a major clinical problem in the elderly population. Loss of dermal integrity leads to increased fragility of the skin and precludes the use of intravenous lines in many cases. Skin tears are a significant concern in elderly individuals directly related to dermal atrophy. Impairment in wound healing is an important clinical sequelae of reduced dermal integrity leading to an increase in the number of the infections and complications following injury. Seborrheic keratosis, which comprise focal areas of epidermal thickening, can occur, possibly representing a response to damage. It has been estimated that 100% of individuals over 50 years of age harbor at least one of these lesion. There is not treatment for dermal atrophy and seborrheic keritoses require excision if they become large enough to cause discomfort or distress.
Therefore, there is a need to develop novel compositions and methods for treating or preventing certain age-related dermal conditions.
Rapamycin is an FDA approved drug that has been in clinical use for over 15 years. Systemic application of rapamycin has been a central part of immuno suppressive therapy for transplant patients in combination with other immuno suppressants. The safety record for systemic use of rapamycin is excellent and few side effects are associated with extended use.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients will apply lotions containing either rapamycin or vehicle to 2 distinct areas of sun exposed skin.|
|Masking:||None (Open Label)|
|Masking Description:||Clinical assessors are blinded to recruitment and treatment assignment.|
|Official Title:||Novel Compositions for Treating or Preventing Dermal Disorders|
|Actual Study Start Date :||September 25, 2017|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||June 30, 2019|
Other Name: sirolimus
- Dermal thickness [ Time Frame: 6-8 months ]dermal thickness as assessed by direct measurement
- Gene expression [ Time Frame: 6-8 months ]immunohistochemistry and gene expression analysis
- Seborrheic Keratosis [ Time Frame: 6-8 months ]clinical severity will be assess using a 1-5 rating scale of severity. Lesions will be evaluated for their progression over the treatment period relative to the known course of growth for Seborrheic Keratoses.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103893
|Contact: Christian Sell, PhDfirstname.lastname@example.org|
|Contact: Christina Chung, MD|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19102-1101|
|Contact: Christina Chung, MD 215-762-5546 email@example.com|
|Contact: Christian Sell 2157628367 firstname.lastname@example.org|
|Sub-Investigator: Ibyonu Lawrence, MD|
|Principal Investigator:||Christian Sell, PhD||Faculty member|
|Principal Investigator:||Christina Chung, MD||Drexel University College of Medicine|
|Principal Investigator:||Inyonu Lawrence, MD||Drexel University College of Medicine|