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IRCT20220727055565N1 IRCT 2022-09-28 Universiti Teknologi MARA Efficacy of Topical Silicone 5% Hydrogel versus Topical Hydrocortisone 1% Ointment in Keloid Treatment measured using POSAS Score. A Randomized, Double-Blind Study Efficacy of Topical Silicone 5% Hydrogel versus Topical Hydrocortisone 1% Ointment in Keloid Treatment measured using POSAS Score. A Randomized, Double-Blind Study 2018-11-13 anticipated 32 Complete https://irct.ir/trial/65103 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization. The patients was allocated to Silicone 5% Hydrogel or Topical Hydrocortisone 1% Ointment group by simple randomization using computer generated sequence. The total number of patients needed in this study was entered to the EpiInfo6 software. Then, the software generated a list of number to which group the patients will be, Blinding description: Double blinding was applied in this study. The investigator and participants were blinded. Only the manufacturer (third party) has the information on the type of treatment received by participants (whether intervention and placebo). The third party provided the Silicone 5% Hydrogel and the Topical Hydrocortisone 1% Ointment. Both Silicone 5% Hydrogel and hydrocortisone 1% ointment were prepared in the same colour and appearance. 1 Keloid Scar. Intervention 1: "Intervention group": The patients were given SILHYD. SILHYD was prepared by the manufacturer as a cream contain of silicone 5% hydrogel, The cream was applied 0.5mg, once daily at the keloid scar pigmentation topically on the keloid scar pigmentation for 12 weeks duration. Intervention 2: "Control group": The patients were given hydrocortisone 1% ointment . hydrocortisone 1% ointment was prepared by the manufacturer as a cream contain of hydrocortisone 1%. The cream was applied 0.5mg, once daily at the keloid scar pigmentation topically on the keloid scar pigmentation for 12 weeks duration. Yes - There is a plan to make this available What will be shared: Efficacy of Topical Silicone 5% Hydrogel versus Topical Hydrocortisone 1% Ointment in Keloid Treatment measured using POSAS Score. A Randomized, Double-Blind Study will be kept for research purpose only When: Will be kept for 7 years until after completion of study To whom: Only for members of the research Conditions: Research only Where to obtain: Principal Investigator How to obtain: Official letter of request will be needed to state reason(s) for request Comments: No
public Liyana Dhamirah Aminuddin
Universiti Teknologi MARA Sungai Buloh Campus, Jalan Hospital
Sungai Buloh Malaysia 47000 0061265000 liyanadhamirah@uitm.edu.my Universiti Teknologi MARA scientific LIYANA DHAMIRAH AMINUDDIN
Universiti Teknologi MARA, Sungai Buloh Campus
Sungai Buloh Malaysia 47000 +60 3-6126 5000 liyanadhamirah@uitm.edu.my Universiti Teknologi MARA Malaysia 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 18 years no limit Both 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 L91.0 Keloid scar Treatment - Other Placebo "Intervention group": The patients were given SILHYD. SILHYD was prepared by the manufacturer as a cream contain of silicone 5% hydrogel, The cream was applied 0.5mg, once daily at the keloid scar pigmentation topically on the keloid scar pigmentation for 12 weeks duration. "Control group": The patients were given hydrocortisone 1% ointment . hydrocortisone 1% ointment was prepared by the manufacturer as a cream contain of hydrocortisone 1%. The cream was applied 0.5mg, once daily at the keloid scar pigmentation topically on the keloid scar pigmentation for 12 weeks duration. 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. Universiti Teknologi MARA Approved 2018-11-13 Research Ethic Committee, Universiti Technologi MARA Research Management Centre, Universiti Teknologi MARA Shah Alam Selangor Darul Ehsan Malaysia