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Evaluation of the effect of hyalase in treatment of keloids

Comparative study of intralesional injection of hyalase, steroid and 5-fluorouracil with intralesional steroid and 5-fluorouracil in patients with keloids

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220115053715N1
Enrollment
16
Registered
2022-01-28
Start date
2022-01-21
Completion date
Unknown
Last updated
2022-02-07

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: Patients in the control group will receive intralesional injections of 5-fluorouracil 0.2 cc from vials of 5-fluorouracil 250mg/5ml and triamcinolone 10 mg in 3 sessions

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with keloid lesions based on clinical diagnosis or pathology who have not received any other treatments for at least 6 months prior to or at the same time as initiating treatment.

Exclusion criteria

Exclusion criteria: Patients with coagulation disorders or hematologic disorders such as hemophilia. Patients taking blood-thinning drugs such as aspirin.

Design outcomes

Primary

MeasureTime frame
Keloid lesion diameter. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Using a ruler and Vancouver scar scale.;Height of keloid lesion. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Using a ruler and Vancouver scar scale.;Keloid lesion color. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observe in natural light and Vancouver scar scale.;Pain. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Asking patient about pain in the lesion.;Consistency. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing and touching the lesion and Vancouver scar scale.;Itching. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Asking patient about presence of itching in the lesion.;Skin atrophy. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing the lesion.;Telangiectasia. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing the lesion in terms of the appearance of arteries as fine red lines on the skin.;Hypopigmentation and hyperpigmentation. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing the lesion in terms of decrease or increase of skin pigments and Vancouver scar scale.;Ulcer. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing the lesion in terms of presence of ulcers.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Sima

Tehran University of Medical Sciences

f-Sima@student.tums.ac.ir+98 21 5561 8989

Outcome results

None listed

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