The effect of photodynamic therapy using methylene blue and micro-needling on patient satisfaction and improvement of scar keloid and hypertrophic after surgery in patients with at least two scars

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240409061456N1

Enrollment

Registered

2024-04-17

Start date

2024-04-20

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Hypertrophic scar and keloid.

Interventions

Intervention 1: Intervention group: Patients with keloid scars receiving micro-needling and light therapy with 1% concentration of methylene blue. Intervention 2: Intervention group: patients with hyp

Eligibility

Sex/Gender

All

Age

5 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with scars after surgery Patients with at least two scars Patients with keloid and hypertrophic scars after surgery At least 4 months have passed since surgery The possibility of telephone and in-person access during the research and 6 months after the end of treatment Age over 5 years

Exclusion criteria

Exclusion criteria: Patients' lack of consent to participate in the research Coagulopathy and use of anticoagulants The presence of fungal skin diseases Active skin infection Patients with one scar Patients with malignancy in other parts of the body Patients with possible scar malignancy active acne Herpes labialis or any other local infection such as warts Moderate to severe chronic skin disease such as eczema and psoriasis Patients undergoing chemotherapy/radiotherapy. Failure to visit the relevant doctor's clinic on the specified date

Design outcomes

Primary

Measure	Time frame
Determining the type of scar using the "Japan Workshop Scale" questionnaire. Timepoint: first visit. Method of measurement: Japan Workshop Scale.;Determining the average improvement of hypertrophic scar using phototherapy and micro-needling in 1% and 0.1% methylene blue concentration. Timepoint: 14 days, 45 days, 3 months and 6 months after the last treatment session. Method of measurement: Observer patient scale and Japanese workshop scale.;Determining the average improvement of keloid scar using phototherapy and micro-needling in 1% and 0.1% methylene blue concentration. Timepoint: 14 days, 45 days, 3 months and 6 months after the last treatment session. Method of measurement: Observer patient scale and Japanese workshop scale.;Determining the average patient satisfaction in the hypertrophic scar group using light therapy and micro-needling in the concentration of 1% and 0.1% methylene blue. Timepoint: 14 days, 45 days, 3 months and 6 months after the last treatment session. Method of measurement: Observer patient scale and Japanese workshop scale.;Determining the average patient satisfaction in the keloid scar group using light therapy and micro-needling in the concentration of 1% and 0.1% methylene blue. Timepoint: 14 days, 45 days, 3 months and 6 months after the last treatment session. Method of measurement: Observer patient scale and Japanese workshop scale.	—

Measure

Time frame

Determining the type of scar using the "Japan Workshop Scale" questionnaire. Timepoint: first visit. Method of measurement: Japan Workshop Scale.;Determining the average improvement of hypertrophic scar using phototherapy and micro-needling in 1% and 0.1% methylene blue concentration. Timepoint: 14 days, 45 days, 3 months and 6 months after the last treatment session. Method of measurement: Observer patient scale and Japanese workshop scale.;Determining the average improvement of keloid scar using phototherapy and micro-needling in 1% and 0.1% methylene blue concentration. Timepoint: 14 days, 45 days, 3 months and 6 months after the last treatment session. Method of measurement: Observer patient scale and Japanese workshop scale.;Determining the average patient satisfaction in the hypertrophic scar group using light therapy and micro-needling in the concentration of 1% and 0.1% methylene blue. Timepoint: 14 days, 45 days, 3 months and 6 months after the last treatment session. Method of measurement: Observer patient scale and Japanese workshop scale.;Determining the average patient satisfaction in the keloid scar group using light therapy and micro-needling in the concentration of 1% and 0.1% methylene blue. Timepoint: 14 days, 45 days, 3 months and 6 months after the last treatment session. Method of measurement: Observer patient scale and Japanese workshop scale.

—

Secondary

Measure	Time frame
Determining the average recovery of hardness score in the keloid group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average recovery of scars hardness score in the hypertrophic group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average recovery score of scar height in the keloid group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average recovery of the scar height score in the hypertrophic group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average improvement of scar redness score in the keloid group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average improvement of scar redness score in the hypertrophic group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average improvement of itching score in the keloid group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining	—

Measure

Time frame

Determining the average recovery of hardness score in the keloid group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average recovery of scars hardness score in the hypertrophic group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average recovery score of scar height in the keloid group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average recovery of the scar height score in the hypertrophic group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average improvement of scar redness score in the keloid group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average improvement of scar redness score in the hypertrophic group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining the average improvement of itching score in the keloid group receiving methylene blue 1% and 0.1%. Timepoint: 14 days, 45 days, three months, and six months after the last treatment session. Method of measurement: patient-observer scale and Japanese workshop scale.;Determining

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshid Sabet Ghadam

Hamedan University of Medical Sciences

ort.mahshid@gmail.com+98 28 3323 3063

Outcome results

None listed

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