Efficacy and safety of microneedle skin patch with and without triamcinolone in keloids treatment compared to local injection of triamcinolone with needle

A single-blind clinical trial pilot study of the efficacy and safety of microneedle skin patch With and without triamcinolone in the treatment of keloid compared to local injection of triamcinolone with a needle

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250228064873N2

Enrollment

Registered

2025-09-25

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

keloid. Hypertrophic scar

Interventions

Intervention 1: Control group: A direct injection of triamcinolone is performed on one of the keloid lesions. Intervention 2: Intervention group: A non-medicated microneedle is placed on one of the ke

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with keloids referred to Razi Hospital who have at least 3 keloids lesions Keloid lesions are between 1 and 4 centimeters in size and have a maximum thickness of one centimeter.

Exclusion criteria

Exclusion criteria: Keloids have not been treated before.

Design outcomes

Primary

Measure	Time frame
Vancouver Clinical Scoring System for Scars. Timepoint: Lesions are scored at each visit based on the Vancouver system (0-month 1-month 2-month 3) and compared at the end of the study. Method of measurement: This system has a score of 0 to 13, as follows: Pigmentation (0-2) Normal 0, Hypopigmentation 1, Hyperpigmentation 2Veins (0-3) Normal 0, Pink 1, Red 2, Purple 3Flexibility (0-5) Normal 0, Supple 1, Yielding 2, Firm 3, Banding 4, Contracture 5Thickness (0-3) Normal (Flat) 0, -2 mm 1, 2-5 mm 2, >5 mm 3.;Pain. Timepoint: After each treatment session. Method of measurement: Visual Analogue Scale(VAS).	—

Measure

Time frame

Vancouver Clinical Scoring System for Scars. Timepoint: Lesions are scored at each visit based on the Vancouver system (0-month 1-month 2-month 3) and compared at the end of the study. Method of measurement: This system has a score of 0 to 13, as follows: Pigmentation (0-2) Normal 0, Hypopigmentation 1, Hyperpigmentation 2Veins (0-3) Normal 0, Pink 1, Red 2, Purple 3Flexibility (0-5) Normal 0, Supple 1, Yielding 2, Firm 3, Banding 4, Contracture 5Thickness (0-3) Normal (Flat) 0, -2 mm 1, 2-5 mm 2, >5 mm 3.;Pain. Timepoint: After each treatment session. Method of measurement: Visual Analogue Scale(VAS).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactIfa Etesami

Tehran University of Medical Sciences

Ifa.etesami@gmail.com+98 21 5561 8989

Outcome results

None listed

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