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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220727055565N1

Enrollment

Registered

2022-09-28

Start date

2018-11-13

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloid Scar. Keloid scar

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Malaysia

Contacts

Public ContactLiyana Dhamirah Aminuddin

Universiti Teknologi MARA

liyanadhamirah@uitm.edu.my0061265000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026