Skin WrinklingNCT00113100
Mechanisms of Skin Repair by Topical Estrogen
A study testing Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG) in people with Skin Wrinkling, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to investigate the way by which estrogen improves the appearance of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post menopausal women, may cause skin to look younger as a consequence of reduced wrinkles. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Wrinkling
- What is being tested?
- Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG)
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jun 2007
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy post-menopausal (without spontaneous menstrual bleeding for at least 1 year) women, and men, at least 50 years of age and any racial/ethnic type.
- Subjects must understand and sign the informed consent prior to participation.
- Subjects must be in generally good health.
- Subjects must be available for follow-up visits to comply with the requirements of the protocol.
- Not on estrogen replacement therapy within the past 3 months.
- No nonsteroidal anti-inflammatory drugs two weeks prior to study entry.
- No topical steroids two weeks prior to study entry.
- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
Who cannot join
- History of keloid formation or hypertrophic scarring.
- History of reaction to lidocaine anesthetic.
- Subjects with significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation and which would impair evaluation of test sites.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
Official title: Mechanisms of Skin Repair by Topical Estrogen in Vivo
The purpose of this study is to investigate the way by which estrogen improves the appearance of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post menopausal women, may cause skin to look younger as a consequence of reduced wrinkles. Collagen is the most abundant protein in human skin and gives skin its strength and shape. Recent data indicate that short-term topical estrogen (17-beta estradiol) treatment increases collagen production in sun damaged skin. This study will compare the molecular and microscopic effects from topical 17-beta estradiol (E2) when applied to the skin for a short-term duration. It is anticipated that the new knowledge from this study will enable development of new ways to improve the function of aged skin.
Read the detailed description
The objectives of the study are to determine if topically-applied 17-beta estradiol (E2), alone or in combination with clobetasol, will produce histological and molecular effects distinguishable from vehicle in human skin. Specifically, the study will focus on regulation of collagen, elastin, and hyaluronic acid production and degradation in human skin, by steroid hormone receptors that are activated by estrogen or clobetasol. The sites to be treated will be buttock, hip, forearm, or facial skin. Subjects will receive between one to twelve vehicle (matching solution without any active ingredients), estrogen, and/or clobetasol topical applications. Skin biopsies of treated areas will be obtained at baseline and at subsequent timepoints. The study will last up to two weeks. Endpoints will include protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue. In addition, we will perform cDNA microanalysis to determine estrogen/clobetasol target genes in human skin. The results from our studies will provide new knowledge regarding the molecular basis of skin aging. This new knowledge will enable development of new ways to improve the function of aged skin.
- Conditions
- Skin Wrinkling
- Being tested
- Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG)
- Keywords
- skin, estrogen, sun damage, Photodamaged Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Endpoints will include, protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2005 (estimated)
- Study startAug 2004
- Primary completionJun 2007
- Study completionJun 2007
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 WrinklingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
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
- NCT00113100
- Sponsor's protocol ID
- Derm 530
- Status last verified
- Aug 2008
- First submitted
- 3 Jun 2005
- Last updated
- 21 May 2015
- Results posted
- No
Publications
Rittie L, Kang S, Voorhees JJ, Fisher GJ. Induction of collagen by estradiol: difference between sun-protected and photodamaged human skin in vivo. Arch Dermatol. 2008 Sep;144(9):1129-40. doi: 10.1001/archderm.144.9.1129.
PubMed 18794456
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Skin Repair by Topical Estrogen in Vivo
- ClinicalTrials.gov ID
- NCT00113100
- Acronym / sponsor ID
- Derm 530
- Conditions
- Skin Wrinkling
- Keywords
- skin, estrogen, sun damage, Photodamaged Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 6 Jun 2005 (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 purpose of this study is to investigate the way by which estrogen improves the appearance of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post menopausal women, may cause skin to look younger as a consequence of reduced wrinkles. Collagen is the most abundant protein in human skin and gives skin its strength and shape. Recent data indicate that short-term topical estrogen (17-beta estradiol) treatment increases collagen production in sun damaged skin. This study will compare the molecular and microscopic effects from topical 17-beta estradiol (E2) when applied to the skin for a short-term duration. It is anticipated that the new knowledge from this study will enable development of new ways to improve the function of aged skin.
Detailed description
The objectives of the study are to determine if topically-applied 17-beta estradiol (E2), alone or in combination with clobetasol, will produce histological and molecular effects distinguishable from vehicle in human skin. Specifically, the study will focus on regulation of collagen, elastin, and hyaluronic acid production and degradation in human skin, by steroid hormone receptors that are activated by estrogen or clobetasol. The sites to be treated will be buttock, hip, forearm, or facial skin. Subjects will receive between one to twelve vehicle (matching solution without any active ingredients), estrogen, and/or clobetasol topical applications. Skin biopsies of treated areas will be obtained at baseline and at subsequent timepoints. The study will last up to two weeks. Endpoints will include protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue. In addition, we will perform cDNA microanalysis to determine estrogen/clobetasol target genes in human skin. The results from our studies will provide new knowledge regarding the molecular basis of skin aging. This new knowledge will enable development of new ways to improve the function of aged skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy post-menopausal (without spontaneous menstrual bleeding for at least 1 year) women, and men, at least 50 years of age and any racial/ethnic type.
- Subjects must understand and sign the informed consent prior to participation.
- Subjects must be in generally good health.
- Subjects must be available for follow-up visits to comply with the requirements of the protocol.
- Not on estrogen replacement therapy within the past 3 months.
Key exclusion criteria (3 listed)
- History of keloid formation or hypertrophic scarring.
- History of reaction to lidocaine anesthetic.
- Subjects with significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation and which would impair evaluation of test sites.
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 |
|---|---|---|
| Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG) | Drug | – |
Primary outcome
Endpoints will include, protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue
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 21 May 2015.
- Derived from this study: PubMed 18794456Rittie L, Kang S, Voorhees JJ, Fisher GJ. Induction of collagen by estradiol: difference between sun-protected and photodamaged human skin in vivo. Arch Dermatol. 2008 Sep;144(9):1129-40. doi: 10.1001/archderm.144.9.1129.
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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 study testing Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG) in people with Skin Wrinkling, 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 8 inclusion and 3 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 21 May 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.
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?
Endpoints will include, protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue. 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 NCT00113100, 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 21 May 2015.