SADBE for Congenital Melanocytic Nevi

ConditionCongenital Melanocytic Nevus

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMassachusetts General Hospital

About this trial

A study to evaluate the safety and efficacy topical squaric acid dibutylester (SADBE) for the neoadjuvant treatment of congenital melanocytic nevi (CMN).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older.

Subject or parents willing and able to give informed consent, and assent as appropriate.

Patients who have a clinical diagnosis of CMN with plans for elective non-urgent excision of part or all of their nevus, with nevus surface area of > 6 cm2.

Disqualifiers

Immunosuppressive therapy with glucocorticoid or other systemic immunosuppressant within 4 weeks of recruitment (except for inhaled corticosteroids for asthma).

History of malignancy.

History of organ transplantation.

Known immunosuppressive disease, including infection with HIV.

Trial design

Design model

Parallel

Treatments tested in this trial

Squaric Acid Dibutyl Ester
Drug
Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration.
Ethanol Solution
Drug
Control

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Squaric Acid Dibutyl Ester (SADBE)Experimental treatment 1 intervention

Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Number of melanocytes per mm2

The number of melanocytes present in the biopsy specimen will be measured. b. Assessment of pigment within stratum corneum, epidermis, and dermis

Time frame

12 weeks

Secondary outcomes

Incidence of Treatment-Emergent Adverse Events

The frequency of adverse events from each treatment arm will be compared.

Time frame

12 weeks

Other outcomes

Clinical appearance of nevi

Treated areas will be compared for pigmentation.

Time frame

12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: