White StriaePhase 1NCT00361361
The Efficacy of 308nm Excimer Laser in White Striae
A Phase 1 study testing Excimer Laser Therapy in people with White Striae and Excimer Laser, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether 308nm Excimer Laser therapy are effective in the color correction of white striae. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- White Striae, Excimer Laser
- What is being tested?
- Excimer Laser Therapy
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Jul 2006to Oct 2006
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- White Striae
Who cannot join
- Red Striae
Trial locations and contacts
1 site in 1 country.
Iran1 site
Skin Research Center, Shaheed Beheshti Medical University
Tehran, 19899
About this study
The purpose of this study is to determine whether 308nm Excimer Laser therapy are effective in the color correction of white striae.
Read the detailed description
The use of excimer laser in modified program in white striae during a few months.
- Conditions
- White Striae, Excimer Laser
- Being tested
- Excimer Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer Laser TherapyDevice
excimer laser is a UV 308nm laser. repeated sessions (10 sessions) needed. once per week.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical darkening of striaes
Secondary outcomes (1)
Colorimetric assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White StriaeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Nima Ostovari, M.D., Study director, Shahid Beheshti University of Medical SciencesParviz Toossi, MD, Study chair, skin research center of shaheed-beheshti medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361361
- Sponsor's protocol ID
- src-ost-1360
- Status last verified
- Nov 2006
- First submitted
- 7 Aug 2006
- Last updated
- 20 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 308nm Excimer Laser in White Striae
- ClinicalTrials.gov ID
- NCT00361361
- Acronym / sponsor ID
- src-ost-1360
- Conditions
- White Striae, Excimer Laser
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 8 Aug 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 purpose of this study is to determine whether 308nm Excimer Laser therapy are effective in the color correction of white striae.
Detailed description
The use of excimer laser in modified program in white striae during a few months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- White Striae
Key exclusion criteria (1 listed)
- Red Striae
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 |
|---|---|---|
| Excimer Laser Therapyexcimer laser is a UV 308nm laser. repeated sessions (10 sessions) needed. once per week. | Device | – |
Primary outcome
Clinical darkening of striaes
1 secondary outcome
Colorimetric assessment
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 20 Feb 2008.
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.
Nima Ostovari, M.D. study director
Shahid Beheshti University of Medical Sciences
Parviz Toossi, MD study chair
skin research center of shaheed-beheshti medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Excimer Laser Therapy in people with White Striae and Excimer Laser, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 20 Feb 2008. 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 Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinical darkening of striaes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2008.