ScarNCT00506363
Safety and Efficacy of Different Onset Times of Treatment With Pulsed Dye Laser on Improvement of Surgical Scars
A study testing pulsed dye laser therapy in people with Scar, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The appearance of skin after surgery plays an important role in patient's self confidence and life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in predisposed individuals after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Scar
- What is being tested?
- pulsed dye laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIran
- Study dates
- Jan 2008to Jan 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical scar with minimum length of 6 cm
Who cannot join
- History of light sensitivity or photodermatoses
- History of adverse reactions to laser treatment
Trial locations and contacts
1 site in 1 country.
Iran1 site
Center for research and training in skin diseases and leprosy
Tehran, 14166
About this study
Official title: The Effect of Different Onset Times of Treatment With 595-nm Pulsed Dye Laser on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial
The appearance of skin after surgery plays an important role in patient's self confidence and life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in predisposed individuals after surgery. Among different kind of lasers, used to improve the appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture, and elasticity of scars. Also, treatment with this technique is noninvasive, minimally uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of different onset times of treatment with pulsed dye laser on improvement of surgical scars.
- Conditions
- Scar
- Being tested
- pulsed dye laser therapy
- Keywords
- scar, surgery, lasers
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed dye laser therapyProcedure or surgery
Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | pulsed dye laser and dynamic cooling device on the day of suture removal Receives: Procedure: pulsed dye laser therapy |
| B | Active comparator | pulsed dye laser and dynamic cooling device 2 months after suture removal Receives: Procedure: pulsed dye laser therapy |
| C | Sham comparator | dynamic cooling device Receives: Procedure: pulsed dye laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pigmentation, pliability, width and height of surgical scars
Measured: baseline, middle of the study, 1 and 3 months after the last treatment session
Secondary outcomes (1)
1- Clinical appearance of scar 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) - Adverse events
Measured: 1 and 3 months after the last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionJan 2009
Why it stopped: The trial was terminated on May 2008 after inclusion of 10 patients due to low recruitment and patient compliance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ScarStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Alireza Firooz, MD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506363
- Sponsor's protocol ID
- 423/2224-B
- Status last verified
- Oct 2009
- First submitted
- 23 Jul 2007
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Nouri K, Jimenez GP, Harrison-Balestra C, Elgart GW. 585-nm pulsed dye laser in the treatment of surgical scars starting on the suture removal day. Dermatol Surg. 2003 Jan;29(1):65-73; discussion 73. doi: 10.1046/j.1524-4725.2003.29014.x.
PubMed 12534515Conologue TD, Norwood C. Treatment of surgical scars with the cryogen-cooled 595 nm pulsed dye laser starting on the day of suture removal. Dermatol Surg. 2006 Jan;32(1):13-20. doi: 10.1111/1524-4725.2006.32002.
PubMed 16393593Paquet P, Hermanns JF, Pierard GE. Effect of the 585 nm flashlamp-pumped pulsed dye laser for the treatment of keloids. Dermatol Surg. 2001 Feb;27(2):171-4. doi: 10.1046/j.1524-4725.2001.00169.x.
PubMed 11207693Alster TS, Williams CM. Treatment of keloid sternotomy scars with 585 nm flashlamp-pumped pulsed-dye laser. Lancet. 1995 May 13;345(8959):1198-200. doi: 10.1016/s0140-6736(95)91989-9.
PubMed 7739306Alam M, Pon K, Van Laborde S, Kaminer MS, Arndt KA, Dover JS. Clinical effect of a single pulsed dye laser treatment of fresh surgical scars: randomized controlled trial. Dermatol Surg. 2006 Jan;32(1):21-5. doi: 10.1111/1524-4725.2006.32029.
PubMed 16393594Manuskiatti W, Wanitphakdeedecha R, Fitzpatrick RE. Effect of pulse width of a 595-nm flashlamp-pumped pulsed dye laser on the treatment response of keloidal and hypertrophic sternotomy scars. Dermatol Surg. 2007 Feb;33(2):152-61. doi: 10.1111/j.1524-4725.2006.33033.x.
PubMed 17300600Davari P, Gorouhi F, Hashemi P, Behnia F, Ghassemi A, Nasiri-Kashani M, Firooz A. Pulsed dye laser treatment with different onset times for new surgical scars: a single-blind randomized controlled trial. Lasers Med Sci. 2012 Sep;27(5):1095-8. doi: 10.1007/s10103-011-1044-5. Epub 2012 Jan 8. No abstract available.
PubMed 22228413
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Onset Times of Treatment With 595-nm Pulsed Dye Laser on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00506363
- Acronym / sponsor ID
- 423/2224-B
- Conditions
- Scar
- Keywords
- scar, surgery, lasers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated on May 2008 after inclusion of 10 patients due to low recruitment and patient compliance.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Jul 2007 (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 appearance of skin after surgery plays an important role in patient's self confidence and life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in predisposed individuals after surgery. Among different kind of lasers, used to improve the appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture, and elasticity of scars. Also, treatment with this technique is noninvasive, minimally uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of different onset times of treatment with pulsed dye laser on improvement of surgical scars.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: pulsed dye laser therapypulsed dye laser and dynamic cooling device on the day of suture removal |
| B | Active comparator | Procedure: pulsed dye laser therapypulsed dye laser and dynamic cooling device 2 months after suture removal |
| C | Sham comparator | Procedure: pulsed dye laser therapydynamic cooling device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgical scar with minimum length of 6 cm
Key exclusion criteria (2 listed)
- History of light sensitivity or photodermatoses
- History of adverse reactions to laser treatment
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 |
|---|---|---|
| pulsed dye laser therapyEach scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals. | Procedure or surgery | A, B, C |
Primary outcome
pigmentation, pliability, width and height of surgical scars
Time frame: baseline, middle of the study, 1 and 3 months after the last treatment session
1 secondary outcome
1- Clinical appearance of scar 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) - Adverse events
Time frame: 1 and 3 months after the last treatment session
Results and safety
The study was stopped early (reason given: The trial was terminated on May 2008 after inclusion of 10 patients due to low recruitment and patient compliance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
- Background: PubMed 12534515Nouri K, Jimenez GP, Harrison-Balestra C, Elgart GW. 585-nm pulsed dye laser in the treatment of surgical scars starting on the suture removal day. Dermatol Surg. 2003 Jan;29(1):65-73; discussion 73. doi: 10.1046/j.1524-4725.2003.29014.x.
- Background: PubMed 16393593Conologue TD, Norwood C. Treatment of surgical scars with the cryogen-cooled 595 nm pulsed dye laser starting on the day of suture removal. Dermatol Surg. 2006 Jan;32(1):13-20. doi: 10.1111/1524-4725.2006.32002.
- Background: PubMed 11207693Paquet P, Hermanns JF, Pierard GE. Effect of the 585 nm flashlamp-pumped pulsed dye laser for the treatment of keloids. Dermatol Surg. 2001 Feb;27(2):171-4. doi: 10.1046/j.1524-4725.2001.00169.x.
- Background: PubMed 7739306Alster TS, Williams CM. Treatment of keloid sternotomy scars with 585 nm flashlamp-pumped pulsed-dye laser. Lancet. 1995 May 13;345(8959):1198-200. doi: 10.1016/s0140-6736(95)91989-9.
- Background: PubMed 16393594Alam M, Pon K, Van Laborde S, Kaminer MS, Arndt KA, Dover JS. Clinical effect of a single pulsed dye laser treatment of fresh surgical scars: randomized controlled trial. Dermatol Surg. 2006 Jan;32(1):21-5. doi: 10.1111/1524-4725.2006.32029.
- Background: PubMed 17300600Manuskiatti W, Wanitphakdeedecha R, Fitzpatrick RE. Effect of pulse width of a 595-nm flashlamp-pumped pulsed dye laser on the treatment response of keloidal and hypertrophic sternotomy scars. Dermatol Surg. 2007 Feb;33(2):152-61. doi: 10.1111/j.1524-4725.2006.33033.x.
- Derived from this study: PubMed 22228413Davari P, Gorouhi F, Hashemi P, Behnia F, Ghassemi A, Nasiri-Kashani M, Firooz A. Pulsed dye laser treatment with different onset times for new surgical scars: a single-blind randomized controlled trial. Lasers Med Sci. 2012 Sep;27(5):1095-8. doi: 10.1007/s10103-011-1044-5. Epub 2012 Jan 8. No abstract available.
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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.
Alireza Firooz, MD principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed dye laser therapy in people with Scar, run by Tehran 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 2 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: stopped early, as of the sponsor's last update on 6 Oct 2009. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The trial was terminated on May 2008 after inclusion of 10 patients due to low recruitment and patient compliance.). Results are not available in the source record.
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?
pigmentation, pliability, width and height of surgical scars (time frame: baseline, middle of the study, 1 and 3 months after the last treatment session). 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 NCT00506363, which also lists 7 linked publications.
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 6 Oct 2009.