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Skin AgingPhase 2NCT00272610

Topical Vitamin A Versus Vehicle Cream in the Treatment of Aged Skin

A Phase 2 study testing 0.4% Retinol Cream in people with Skin Aging and Purpura, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Skin Aging, Purpura
What is being tested?
0.4% Retinol Cream
How many people
50 participants
Where
1 siteUnited States
Study dates
Sep 2000to Feb 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Topical Vitamin A (All-trans Retinol) Versus Vehicle Cream in the Treatment of Aged Skin

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).

Read the 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.

Conditions
Skin Aging, Purpura
Being tested
0.4% Retinol Cream
Keywords
Skin Aging, Bateman's Purpura
Medical subject headings
Purpura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.4% Retinol CreamDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surface Roughness

  2. Fine wrinkles

  3. Hyperpigmentation

  4. Purpura

Secondary outcomes (3)
  1. Collagen content of skin biopsies

  2. Glycosaminoglycan expression

  3. CRABP-II expression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2006 (estimated)
  2. Study startSep 2000
  3. Study completionFeb 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00272610
Sponsor's protocol ID
Derm 443
Status last verified
Sep 2006
First submitted
3 Jan 2006
Last updated
24 Jun 2015
Results posted
No

Publications

  • 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.

    PubMed 17515510

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.4% Retinol Cream in people with Skin Aging and Purpura, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surface Roughness. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00272610, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.

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