Sirolimus Gel for Acanthosis Nigricans

Overseen By Kayla Zafar, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Narrows Institute for Biomedical Research

Must not be taking: Retinoids, Hydroquinones, Corticosteroids, others

Disqualifiers: Pregnancy, Malignant tumor, Dyslipidemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

5 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot use certain topical treatments like retinoids, hydroquinones, corticosteroids, or depigmenting agents within one month before the study, or oral retinoids within six months before the study. Also, you cannot have used medications with mTOR inhibitory action within 12 months before the first visit.

Is Sirolimus Gel safe for use in humans?

Sirolimus has been used in humans primarily as an immunosuppressive drug, and while it can cause skin-related side effects like acne-like eruptions, these effects are generally known and documented. However, specific safety data for Sirolimus Gel in treating acanthosis nigricans is not available, so it's important to discuss potential risks with a healthcare provider. ^{1 2 3 4 5}

How is the drug Sirolimus Gel unique in treating acanthosis nigricans?

Sirolimus Gel is unique because it uses sirolimus, a drug known for its immunosuppressive properties, in a topical form, which is different from other treatments like tretinoin creams or chemical peels that focus on exfoliation or skin renewal. This approach may offer a novel mechanism by potentially targeting the underlying pathways involved in skin thickening and pigmentation. ^{1 5 6 7 8}

What is the purpose of this trial?

The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans

Research Team

Jared Jagdeo, MD MS

Principal Investigator

SUNY Downstate Health Sciences University Department of Dermatology

Eligibility Criteria

Adults 18+ with a clinical diagnosis of Acanthosis Nigricans can join this trial if they consent and follow study instructions. Excluded are pregnant individuals, those in other studies, recent recipients of investigational drugs/devices, people with hypersensitivity to Sirolimus or high cholesterol/triglycerides, and anyone unable to avoid sun/tanning devices.

Inclusion Criteria

Able and willing to provide written and verbal informed consent

I have been diagnosed with acanthosis nigricans.

I can follow the study rules and attend all visits.

Exclusion Criteria

Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study

Pregnant, lactating, or is planning to become pregnant during the study

Subject is currently enrolled in an investigational drug or device study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sirolimus 0.2% topical gel for 12 weeks

12 weeks

Visits at baseline, week 4, week 8, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sirolimus

Trial Overview The trial is testing the safety and effectiveness of a topical gel called Sirolimus 0.2% for treating Acanthosis Nigricans. Participants will apply the gel as instructed to see if it improves their skin condition.

Participant Groups

Group I: Patients with Acanthosis Nigricans Experimental Treatment 1 Intervention

Patients with the diagnosis of acanthosis nigricans

Who Is Running the Clinical Trial?

Narrows Institute for Biomedical Research

Lead Sponsor

Trials

5

Recruited

650+

Nobelpharma

Industry Sponsor

Trials

36

Recruited

2,200+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparing the efficacy and safety profiles of 0.025% and 0.05% tretinoin creams in treating acanthosis nigricans: a randomized double-blinded study. [2023]

2. Denmark pubmed.ncbi.nlm.nih.gov

Mucocutaneous disorders in renal transplant recipients receiving sirolimus-based immunosuppressive therapy: a prospective, case-control study. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Sirolimus-induced acneiform eruption. [2013]

4. India pubmed.ncbi.nlm.nih.gov

Sirolimus as Long-term Graft-versus-host-disease Prophylaxis in Haploidentical Hematopoietic Stem Cell Transplant Recipients for Non-malignant Disorders is Associated with High Incidence of Acneiform Lesions. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The randomized trials of 10% urea cream and 0.025% tretinoin cream in the treatment of acanthosis nigricans. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Topical therapy with tretinoin and ammonium lactate for acanthosis nigricans associated with obesity. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Treatment of acanthosis nigricans with sequential salicylic acid-mandelic acid combination peel and maintenance with glycolic acid-urea combination cream: A retrospective pilot study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Fractional carbon dioxide laser versus trichloroacetic acid peel in the treatment of pseudo-acanthosis nigricans. [2022]