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Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery

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ClinicalTrials.gov Identifier: NCT02487212
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Woraphong Manuskiatti, M.D., Mahidol University

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.

Condition or disease Intervention/treatment Phase
Hypertrophic Scars Drug: 0.05% Clobetasol propionate Drug: Petrolatum gel Device: Fractional Erbium:Yag (2,940-nm) laser Phase 4

Detailed Description:

Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation.

Recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars Steroids

Arm Intervention/treatment
Active Comparator: Laser+Topical corticosteroid
Hypertrophic scars were treated with fractional Erbium: Yttrium aluminium garnet (YAG) (2,940-nm) laser, then 0.05% Clobetasol propionate ointment was immediately applied on the perforated scar on one side
Drug: 0.05% Clobetasol propionate
0.05% Clobetasol propionate was rubbed for 2 minutes on one side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser. The treatment was done in every 2 weeks for 4 sessions

Device: Fractional Erbium:Yag (2,940-nm) laser
The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions

Placebo Comparator: Laser+Petrolatum gel
Hypertrophic scars were treated with fractional Erbium: YAG (2,940-nm) laser, then topical petrolatum gel was immediately applied on the perforated scar on the other side
Drug: Petrolatum gel
Petrolatum gel was rubbed for 2 minutes on the other side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser.The treatment was done in every 2 weeks for 4 sessions

Device: Fractional Erbium:Yag (2,940-nm) laser
The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions




Primary Outcome Measures :
  1. Scar thickness measured by digital calliper [ Time Frame: change from baseline in scar thickness at 6 months ]

Secondary Outcome Measures :
  1. Patient and observer scar assessment scale [ Time Frame: Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female subjects with age range 18-60 years;
  • Subject with hypertrophic scar from abdominal surgery for at least 3 months;
  • Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months

Exclusion Criteria:

  • Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;
  • Subject who smoke cigarette;
  • Subject who was treated with Intralesional corticosteroid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487212


Locations
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Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University

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Responsible Party: Woraphong Manuskiatti, M.D., Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02487212     History of Changes
Other Study ID Numbers: 614/2556 (EC2)
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015
Keywords provided by Woraphong Manuskiatti, M.D., Mahidol University:
fractional laser
hypertrophic scar
topical corticosteroid
laser assisted delivery systems
Additional relevant MeSH terms:
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Hypertrophy
Cicatrix, Hypertrophic
Cicatrix
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Clobetasol
Petrolatum
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Emollients
Dermatologic Agents