Topical Vitamin A Versus Vehicle Cream in the Treatment of Aged Skin
Information source: University of Michigan
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Aging; Purpura
Intervention: 0.4% Retinol Cream (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Michigan Official(s) and/or principal investigator(s): John J Voorhees, MD, Study Chair, Affiliation: University of Michigan
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).
Clinical Details
Official title: Topical Vitamin A (All-trans Retinol) Versus Vehicle Cream in the Treatment of Aged Skin
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: Surface RoughnessFine wrinkles Hyperpigmentation Purpura
Secondary outcome: Collagen content of skin biopsiesGlycosaminoglycan expression CRABP-II expression
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.
Eligibility
Minimum age: 70 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Michigan, Ann Arbor, Michigan 48109, United States
Additional Information
Starting date: September 2000
Last updated: June 23, 2015
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