AviClear for Hidradenitis Suppurativa

Overseen By Leigh Nattkemper, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Retinoids, Anticoagulants, Immunosuppressants, others

Disqualifiers: Pregnancy, Coagulation disorders, Immunosuppression, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using retinoids, immunosuppressive medications, or medications that increase sensitivity to light, you may need to stop them before participating.

What safety data exists for AviClear (imiquimod) in humans?

Imiquimod, used in various treatments, has shown some common side effects like redness and skin irritation in about 24% of patients, with less common effects including skin damage and pain. In a study with rabbits, imiquimod injections did not cause respiratory distress or significant inflammation, suggesting it is generally safe. ^{1 2 3 4 5}

How does the treatment AviClear differ from other treatments for hidradenitis suppurativa?

AviClear is unique because it is a low-invasive treatment option for hidradenitis suppurativa, potentially offering a successful outcome for early stages of the condition, unlike more aggressive treatments like surgery or anti-TNF-alpha drugs such as adalimumab. ^{6 7 8 9 10}

What is the purpose of this trial?

The objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of HS.

Research Team

Ariel E Eber, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals with Hidradenitis Suppurativa (HS), a chronic skin condition. Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis of HS and meet certain health standards.

Inclusion Criteria

I can safely undergo laser therapy.

Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form

I am either female or male.

Exclusion Criteria

Still healing from another treatment in the target area according to investigator's discretion

I have a blood clotting disorder or am on blood thinners.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Cutera 1726 nm laser system (AviClear) for Hidradenitis Suppurativa

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

19 weeks

Treatment Details

Interventions

• AviClear

Trial Overview The trial is testing the safety and effectiveness of AviClear, which is Cutera's 1726 nm laser system designed to treat HS. The goal is to see how well it works and monitor any side effects in patients receiving this treatment.

Participant Groups

Group I: AviClear Group Experimental Treatment 1 Intervention

Participants will be in this group for up to 43 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

In a preclinical study involving six rabbits, injecting imiquimod into the vocal fold mucosa was found to be safe, with no significant signs of respiratory distress or adverse changes in vocal fold appearance observed during evaluations.

While there was a transient increase in serum interferon α (IFNα) levels after the injection, no acute inflammatory processes or scarring were detected, suggesting that imiquimod could be a promising targeted therapy for recurrent respiratory papillomatosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imiquimod Injection to Rabbit Vocal Folds: A Preliminary, Preclinical Investigation. Teng, SE., Dion, GR., Sin, DN., et al.[2018]

In a randomized study, daily applications of 5% imiquimod cream resulted in a 75% clearance rate of lesions in female patients with molluscum contagiosum and a 50% clearance rate in those with external genital warts, demonstrating its efficacy in treating these conditions.

The most common side effect was erythema, occurring in 24% of patients, while other side effects included excoriation (16%), erosions (10%), and pain (4%), indicating that while imiquimod is effective, it can also cause notable adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study on the use of imiquimod for the treatment of genital molluscum contagiosum and genital warts in female patients. Puri, N.[2021]

Imiquimod cream (2% or 5%) was found to be effective in treating external genital warts, achieving complete clearance in 51% of HIV-negative patients compared to only 6% in placebo groups, with a number needed to treat of 2.2.

The treatment also resulted in at least a 50% reduction in wart area for 72% of patients using the 5% cream, while adverse effects were rare and similar to those seen with placebo, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imiquimod for the treatment of genital warts: a quantitative systematic review. Moore, RA., Edwards, JE., Hopwood, J., et al.[2019]

Topical omiganan 2.5% is safe and well-tolerated in patients with external anogenital warts (AGW) and vulvar high-grade squamous intraepithelial lesions (HSIL), with no serious adverse events reported and all mild side effects being transient.

After 12 weeks of treatment, omiganan significantly reduced human papillomavirus (HPV) load by 96.6% in AGW patients, indicating its potential efficacy in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions. Rijsbergen, M., Rijneveld, R., Todd, M., et al.[2022]

In two open-label studies involving 600 female patients, imiquimod 5% cream led to a 75% complete clearance rate of anogenital warts after up to 16 weeks of treatment.

The treatment was well-tolerated, with erythema being the most common side effect, and it remained effective for patients who experienced wart recurrence, with 75% achieving total clearance upon retreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imiquimod 5% cream in the treatment of anogenital warts in female patients. Buck, HW., Fortier, M., Knudsen, J., et al.[2019]

Hidradenitis Suppurativa (HS) is often misdiagnosed, leading to delayed treatment and worsening symptoms, which can result in the need for invasive procedures like surgery or aggressive therapies such as anti-TNF-alpha medications.

The study presents a low-invasive treatment option that shows successful outcomes for early-stage HS, emphasizing the need for early diagnosis and increased awareness among healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and histological changes in Hidradenitis suppurativa following 1064 nm nd:YAG intralesional laser treatment. Zerbinati, N., D'Este, E., Ini, L., et al.[2019]

Adalimumab is the only officially approved treatment for moderate-to-severe hidradenitis suppurativa (HS) and has shown a cumulative response rate of 58% in case reports involving 42 patients.

In phase III trials (PIONEER studies I and II), adalimumab demonstrated significantly higher efficacy compared to placebo at week 12, with adverse events being similar to those experienced by placebo patients, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on adalimumab in the treatment of active moderate-to-severe hidradenitis suppurativa. Fotiadou, C., Vakirlis, E., Ioannides, D.[2020]

Adalimumab administered weekly is effective for treating hidradenitis suppurativa (HS), showing a significant reduction in Dermatology Life Quality Index (DLQI) scores compared to placebo, with a difference of 2.8 points.

Infliximab also shows moderate-quality evidence of benefit for HS, but evidence for other treatments is less robust or lacking, making it difficult to draw further conclusions about their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for Hidradenitis Suppurativa: Updated Summary of an Original Cochrane Review. Ingram, JR.[2018]

In a study involving 8 patients with hidradenitis suppurativa and chronic recurrent staphylococcal abscess, treatment with Staphage Lysate led to significant improvements in symptoms, including reduced drainage and pain, after 12 weeks of therapy.

All patients experienced shorter inflammatory periods, and while some mild complications occurred, they were minimal, suggesting that Staphage Lysate could be a beneficial adjuvant treatment for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary report on the use of Staphage Lysate for treatment of hidradenitis suppurativa. Kress, DW., Graham, WP., Davis, TS., et al.[2019]

Adalimumab administered weekly significantly improved quality of life for patients with hidradenitis suppurativa (HS), achieving a clinically important difference in the Dermatology Life Quality Index compared to placebo, although this finding is based on a single study.

Infliximab also showed effectiveness in improving quality of life scores after 8 weeks, while adalimumab given every other week was found to be ineffective, highlighting the need for more extensive trials to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for hidradenitis suppurativa: a Cochrane systematic review incorporating GRADE assessment of evidence quality. Ingram, JR., Woo, PN., Chua, SL., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Imiquimod Injection to Rabbit Vocal Folds: A Preliminary, Preclinical Investigation. [2018]

2. India pubmed.ncbi.nlm.nih.gov

A study on the use of imiquimod for the treatment of genital molluscum contagiosum and genital warts in female patients. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Imiquimod for the treatment of genital warts: a quantitative systematic review. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions. [2022]

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

Imiquimod 5% cream in the treatment of anogenital warts in female patients. [2019]

6. Italy pubmed.ncbi.nlm.nih.gov

Clinical and histological changes in Hidradenitis suppurativa following 1064 nm nd:YAG intralesional laser treatment. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on adalimumab in the treatment of active moderate-to-severe hidradenitis suppurativa. [2020]

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

Interventions for Hidradenitis Suppurativa: Updated Summary of an Original Cochrane Review. [2018]

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

A preliminary report on the use of Staphage Lysate for treatment of hidradenitis suppurativa. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Interventions for hidradenitis suppurativa: a Cochrane systematic review incorporating GRADE assessment of evidence quality. [2018]