Efficacy of Topical Silicone 5% Hydrogel versus Topical Hydrocortisone 1% Ointment in Keloid Treatment measured using POSAS Score. A Randomized, Double-Blind Study

Phase 1

• Conditions: Keloid Scar.; Keloid scar; L91.0

• Registration Number: IRCT20220727055565N1
• Lead Sponsor: niversiti Teknologi MARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Age 18 or above
Educationally competence able to participate in the study for 12 weeks
At least two keloid scars on the same anatomical site or having one large keloid scar exceeding 5cm

Exclusion Criteria

History of allergy or hypersensitivity responses to any component of the medications or dressing used in the study
Active primary or secondary dermatoses superimposed on the keloid
Active skin infection, connective tissue disorders and diabetes mellitus.
Patients who were educationally incompetence and were not able to understand the Patient and Observer Scar Assessment Scale (POSAS)
Had a history of keloid treatment (shorter than eight weeks)
Pregnant
Lactating
Keloid less than 8 weeks

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effects of keloid scar condition. Timepoint: at baseline (before intervention), at week-4, at week-8 and week-12 (4 weeks interval) after completion of the intervention. Method of measurement: Validate scoring tool Patient and Observer Scar Assessment Scale (POSAS).;To compare the effects of pigmentation keloid scar. Timepoint: at baseline (before intervention), at week-4, at week-8 and week-12 (4 weeks interval) after completion of the intervention. Method of measurement: Mexameter.