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WithdrawnNCT00506090Updated Oct 6, 2009

Safety and Efficacy of Different Intervals of Pulsed Dye Laser Sessions on Improvement of Surgical Scars

An interventional study of pulsed dye laser therapy in Scar, sponsored by Tehran University of Medical Sciences. Withdrawn at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-10-06.

Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Because of unsatisfactory results of previous trial which assessed the effect of different onset times of PDL on surgical scars.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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. 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 intervals of pulsed dye laser sessions on improvement of surgical scars.

02

Conditions studied

  • Scar

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Keywords

  • scar
  • surgery
  • lasers
03

In context

Cicatrix

307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

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Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Surgical scar with minimum length of 6 cm

Exclusion criteria

Exclusion Criteria:

  • History of light sensitivity or photodermatoses
  • History of adverse reactions to laser treatment
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    A

    pulsed dye laser and dynamic cooling device at 3 weeks intervals

    Procedure: pulsed dye laser therapy

  • Active comparator
    B

    pulsed dye laser and dynamic cooling device at 6 weeks intervals

    Procedure: pulsed dye laser therapy

  • Sham comparator
    C

    dynamic cooling device

    Procedure: pulsed dye laser therapy

Interventions

  • Procedurepulsed dye laser therapy

    Treatment will begin on the day of suture removal. 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 at 3 weeks intervals for 6 sessions. Another part will be treated with pulsed dye laser and dynamic cooling device at 6 weeks intervals for 6 sessions. Only dynamic cooling device will be used for remaining part serving as control.

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What researchers measure

Primary outcomes

  1. pigmentation, pliability, width and height of surgical scars

    Time frame: baseline, middle of the study, 1 and 3 months after the last treatment session

Secondary outcomes

  1. 1- Clinical appearance of surgical scars 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) 3- Adverse events

    Time frame: 1 and 3 months after the last treatment session

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Study locations

1 site
  • Center for research and training in skin diseases and leprosy
    Tehran, 14166, Iran, Islamic Republic of
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References and documents

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 12534515 ↗
  • Conologue 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 16393593 ↗
  • Paquet 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 11207693 ↗
  • Alster 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 7739306 ↗
  • Alam 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 16393594 ↗
  • Manuskiatti 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 17300600 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00506090
Lead sponsor
Tehran University of Medical Sciences
First posted
Jul 25, 2007
Start date
Jul 2007
Last update
Oct 6, 2009

Study contacts

Alireza Firooz, MD
principal investigator · Tehran University of Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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