Skip to content

Comparison between fluocinolone plus tacrolimus and fluocinolone plus NBUVB in the treatment of localized morphea

Comparison between fluocinolone plus tacrolimus and fluocinolone plus NBUVB in the treatment of localized morphea

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091012002581N7
Enrollment
20
Registered
2020-09-05
Start date
2020-04-20
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Localized morphea. Localized scleroderma [morphea]

Interventions

Intervention 1: Intervention group: 10 people with localized morphea will be treated with topical ointment fluocinolone and tacrolimus 0.1 percent every 12 hours for 4 months. Intervention 2: Control

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The disease is in its active phase Patients have not received any treatment in the past 6 weeks Existence of at least one morphea plaque with a total area of cm2 10 Lack of use of immunosuppressants, penicillamine, interferon gamma, or phototherapy in the last three months

Exclusion criteria

Exclusion criteria: Systemic sclerosis or pseudosclerosis Existence of a history of side effects in previous use of tacrolimus (hypersensitivity, intolerance) Contraceptive radiation therapy Pregnant women or those who are planning to become pregnant during treatment Breastfeeding women Infectious active lesion at the site of morphea plaque Recent vaccinations (28 days before the start of the study) Borrelia burgdorferi infection (serological diagnosis)

Design outcomes

Primary

MeasureTime frame
Morphea waste area. Timepoint: Months 0 -2- 4. Method of measurement: Measurement with ruler.;Dispigmentation. Timepoint: Months 0 -2- 4. Method of measurement: 16 megapixel digital camera from a distance of 10 cm from the lesion.;Hardness. Timepoint: Months 0 -2- 4. Method of measurement: Observe and pinch through the lesion.;Atrophy. Timepoint: Months 0 -2- 4. Method of measurement: View and touch as well as digital camera.

Secondary

MeasureTime frame
Patient satisfaction after treatment. Timepoint: Months 0- 2- 4. Method of measurement: Patient serial examination - questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hamide Herizchi Ghadim

Tabriz University of Medical Sciences

Drherizchi@yahoo.com+98 41 8236 3549

Outcome results

None listed

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