Topical Vitamin A Versus Vehicle Cream in the Treatment of Aged Skin
Primary Purpose
Skin Aging, Purpura
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.4% Retinol Cream
Sponsored by
About this trial
This is an interventional prevention trial for Skin Aging focused on measuring Skin Aging, Bateman's Purpura
Eligibility Criteria
Inclusion Criteria: Male and female 70 years of age or older history of Bateman's purpura on arms Relatively good general health and able to perform daily tasks Exclusion Criteria: Sensitivity to any formulation ingredients History of Cardiovascular disease with continuing deficits (example: partial paralysis) Participated in any clinical trials within last 30 days Topical steroids or other drugs two weeks prior to study entry (short-term application of topical antimicrobials is allowed) Hormone replacement therapy within last 6 months.
Sites / Locations
- University of Michigan
Outcomes
Primary Outcome Measures
Surface Roughness
Fine wrinkles
Hyperpigmentation
Purpura
Secondary Outcome Measures
Collagen content of skin biopsies
Glycosaminoglycan expression
CRABP-II expression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00272610
Brief Title
Topical Vitamin A Versus Vehicle Cream in the Treatment of Aged Skin
Official Title
Topical Vitamin A (All-trans Retinol) Versus Vehicle Cream in the Treatment of Aged Skin
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Michigan
4. Oversight
5. Study Description
Brief Summary
The objectives of this study are to evaluate the safety and efficacy of 0.5% retinol (Vitamin A) versus it's vehicle cream in the treatment and prevention of skin aging and Bateman's Purpura (bruising).
Detailed Description
Human skin becomes thinner and looses its elasticity with increasing age. These features of intrinsic skin aging are due to reduction in collagen synthesis with a concomitant increase in collagen and elastic fiber breakdown by matrix metalloproteinase (MMPs). In addition to these changes that occur simply from the passage of time, skin that is chronically exposed to the sun undergoes accelerated aging process referred to as photoaging. Here sun causes further alterations in dermal matrix by transiently inducing MMPs with each irradiation. Bateman's purpura (BP) is a bruised lesion that is commonly seen on the sun-exposed extensor surfaces of forearms and hands in elderly individuals. It is of no medical significance. However, to those afflicted, BP is often a great source of distress for its unsightliness and the obvious sign of aging it represents. The pathophysiology of BP has not been rigorously studied. Its exclusive presence on the sun-exposed surfaces of frequently traumatized areas suggests that photoaging associated loss of supporting structures around cutaneous blood vessels render the vessels easily torn by shearing injuries, thus causing purpura.
Topical use of tretinoin (RA) 0.1% cream has been demonstrated to improve clinical as well as histologic changes associated with photodamaged skin. Improvement in skin wrinkles by RA appears to be related to dermal changes. RA causes accumulation of epidermal and dermal TGF-alpha 1, a cytokine known to stimulate the synthesis of collagen I and VII, both of which, by ultrastructural criteria, are increased by RA in photodamaged skin. In fact, induction of dermal collagen formation by topically applied RA has been demonstrated in animal studies, and this has been confirmed in human studies. Therefore, it is postulated that topical treatment of BP prone skin with RA would buttress up cutaneous blood vessels by increasing the supporting collagenous structures around them. Such vessels ought to withstand shearing forces better, which would lead to some protection against the development of BP.
Retinol is a precursor to RA. When applied to human skin, it mediates all the effects that RA causes, but does so with much less skin irritation. Therefore, it is expected to be better tolerated by elderly skin than RA. In a seven day treatment study of elderly patients, retinol has been shown to induce mRNA levels of procollagen molecules in human skin in vivo. Therefore, it is hypothesized to improve the thin skin of elderly by increasing the synthesis of more collagen in both the photoaged, and hence improve BP, and the intrinsically aged human skin without causing significant irritant skin reaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Aging, Purpura
Keywords
Skin Aging, Bateman's Purpura
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
0.4% Retinol Cream
Primary Outcome Measure Information:
Title
Surface Roughness
Title
Fine wrinkles
Title
Hyperpigmentation
Title
Purpura
Secondary Outcome Measure Information:
Title
Collagen content of skin biopsies
Title
Glycosaminoglycan expression
Title
CRABP-II expression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female
70 years of age or older
history of Bateman's purpura on arms
Relatively good general health and able to perform daily tasks
Exclusion Criteria:
Sensitivity to any formulation ingredients
History of Cardiovascular disease with continuing deficits (example: partial paralysis)
Participated in any clinical trials within last 30 days
Topical steroids or other drugs two weeks prior to study entry (short-term application of topical antimicrobials is allowed)
Hormone replacement therapy within last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Voorhees, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17515510
Citation
Kafi R, Kwak HS, Schumacher WE, Cho S, Hanft VN, Hamilton TA, King AL, Neal JD, Varani J, Fisher GJ, Voorhees JJ, Kang S. Improvement of naturally aged skin with vitamin A (retinol). Arch Dermatol. 2007 May;143(5):606-12. doi: 10.1001/archderm.143.5.606.
Results Reference
derived
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Topical Vitamin A Versus Vehicle Cream in the Treatment of Aged Skin
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