A Phase 4 interventional study of 0.05% Clobetasol propionate and Petrolatum gel in Hypertrophic Scars, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-01.
Sponsored by Mahidol University · Phase 4, Interventional, and Treatment
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.
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.
656 studies on the registry are indexed under Hypertrophy; 87 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 460 interventional studies indexed under Hypertrophy.
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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 · Device: Fractional Erbium:Yag (2,940-nm) laser
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 · Device: Fractional Erbium:Yag (2,940-nm) laser
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
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
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
Scar thickness measured by digital calliper
Time frame: change from baseline in scar thickness at 6 months
Patient and observer scar assessment scale
Time frame: Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Mahidol University