Solar ElastosisNCT01892150
Histologic Response to UVA and UVB Exposure During the Use of Sunscreen
A study testing Sunscreen in people with Solar Elastosis, run by Mahidol University at 1 site in Thailand.
Trial summary
Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Solar Elastosis
- What is being tested?
- Sunscreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Jul 2013
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects aged 35-65 years who were scheduled for abdominoplasty
- the excised area should be larger than 18x10 cm2
- no skin diseases or lesions on the excised area
- no topical treatment on excised area more than 1 month prior to this study
Who cannot join
- pregnancy
- lactation
- have tattoo or striae distensae on abdomen
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Histologic Response to UVA and UVB Exposure During the Use of Sunscreen With Anti-inflammatory and Anti-oxidant Properties - A Pilot Study
Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.
Read the detailed description
Premature aging can be prevented by using sunscreen. Currently, anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.
- Conditions
- Solar Elastosis
- Being tested
- Sunscreen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunscreenOther
Apply sunscreen before and after UVA and UVB irradiation
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen | Experimental | Apply sunscreen before and after UVA and UVB irradiation Receives: Other: Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
H&E Staining
Review difference in H\&E staining in tissue biopsy before and after UVA / UVB irradiation
Measured: 2 Months
Secondary outcomes (1)
Tyrosinase Staining
Review difference in Tyrosinase staining in tissue biopsy before and after UVA / UVB irradiation to evaluate the effects of pigment darkening after UV exposure
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionJul 2013
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 Solar ElastosisStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rungsima Wanitphakdeedecha, MD, MA, MSc, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892150
- Sponsor's protocol ID
- Siriraj-Eucerin02
- Other IDs
- 721/2555(EC2)
- Status last verified
- Mar 2014
- First submitted
- 23 May 2013
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lavker RM, Gerberick GF, Veres D, Irwin CJ, Kaidbey KH. Cumulative effects from repeated exposures to suberythemal doses of UVB and UVA in human skin. J Am Acad Dermatol. 1995 Jan;32(1):53-62. doi: 10.1016/0190-9622(95)90184-1.
PubMed 7822517
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic Response to UVA and UVB Exposure During the Use of Sunscreen With Anti-inflammatory and Anti-oxidant Properties - A Pilot Study
- ClinicalTrials.gov ID
- NCT01892150
- Acronym / sponsor ID
- Siriraj-Eucerin02
- Conditions
- Solar Elastosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Jul 2013 (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.
Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.
Detailed description
Premature aging can be prevented by using sunscreen. Currently, anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunscreen | Experimental | Other: SunscreenApply sunscreen before and after UVA and UVB irradiation |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects aged 35-65 years who were scheduled for abdominoplasty
- the excised area should be larger than 18x10 cm2
- no skin diseases or lesions on the excised area
- no topical treatment on excised area more than 1 month prior to this study
Key exclusion criteria (3 listed)
- pregnancy
- lactation
- have tattoo or striae distensae on abdomen
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 |
|---|---|---|
| SunscreenApply sunscreen before and after UVA and UVB irradiation | Other | Sunscreen |
Primary outcome
H&E Staining
Time frame: 2 Months
Review difference in H\&E staining in tissue biopsy before and after UVA / UVB irradiation
1 secondary outcome
Tyrosinase Staining
Time frame: 2 Months
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 31 Mar 2014.
- Results publication: PubMed 7822517Lavker RM, Gerberick GF, Veres D, Irwin CJ, Kaidbey KH. Cumulative effects from repeated exposures to suberythemal doses of UVB and UVA in human skin. J Am Acad Dermatol. 1995 Jan;32(1):53-62. doi: 10.1016/0190-9622(95)90184-1.
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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.
Rungsima Wanitphakdeedecha, MD, MA, MSc principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunscreen in people with Solar Elastosis, run by Mahidol University at 1 site in Thailand.
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 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 31 Mar 2014. 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 Thailand. 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?
H&E Staining (time frame: 2 Months). 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 NCT01892150, 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 31 Mar 2014.