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.
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.
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.
Surface Roughness
Fine wrinkles
Hyperpigmentation
Purpura
Secondary outcomes (3)
Collagen content of skin biopsies
Glycosaminoglycan expression
CRABP-II expression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study startSep 2000
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Investigators
- John J Voorhees, MD, Study chair, University of Michigan
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Vitamin A (All-trans Retinol) Versus Vehicle Cream in the Treatment of Aged Skin
- ClinicalTrials.gov ID
- NCT00272610
- Acronym / sponsor ID
- Derm 443
- Conditions
- Skin Aging, Purpura
- Keywords
- Skin Aging, Bateman's Purpura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2000
- Study completion
- Feb 2002
- First posted
- 6 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.4% Retinol Cream | Drug | – |
Primary outcome
Surface Roughness
Fine wrinkles
Hyperpigmentation
Purpura
3 secondary outcomes
Collagen content of skin biopsies
Glycosaminoglycan expression
CRABP-II expression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Derived from this study: PubMed 17515510Kafi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Voorhees, MD study chair
University of Michigan
1 site in 1 country: see every site and its status.
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.