Treatment of Basal Cell Carcinoma (BCC) of the Skin, of the Morpheiform, Infiltrative, and Noduloulcerative Types in Inoperable Patients and Not Suitable for Radiotherapy Using Formulated Methylene Blue

What Was Tested

In this phase 3 trial, researchers set out to test Methylene blue (non-peptide stack partner).

This condition mainly affects adults and often occurs on the head or neck.

Some patients cannot undergo surgery or radiotherapy due to tumor invasion, recurrence, or health limitations.

It had 1 arm (groups): Formulated Methylene Blue Treatment Arm (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histopathologically confirmed diagnosis of morpheaform, infiltrative, or noduloulcerative basal cell carcinoma (BCC). Provision of written informed consent to participate in the study. Lack of willingness or eligibility for surgical excision or radiotherapy, or contraindication to intralesional medical treatments such as interferon-alpha or 5-fluorouracil (5-FU). Age ≥ 18 years. Lesion size \< 2 cm in diameter.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: superficial or nodular subtype of basal cell carcinoma; withdrawal of consent at any stage of the study; pregnancy or breastfeeding.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-10-21 with completion listed for 2026-01-20.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of Wound Healing and Tumor Regression in Inoperable Basal Cell Carcinoma Treated with Topical Formulated Methylene Blue (time frame: Baseline, every week for 4 weeks during treatment, and at 8 weeks post-treatment follow-up).

It also tracked 1 secondary outcome, for example Changes in Inflammatory and Biochemical Markers Before and After Treatment with Topical Formulated Methylene Blue.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Methylene blue (non-peptide stack partner) in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.