Lasers for Sebaceous Hyperplasia

Overseen By DermCTU

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Pregnancy, Poor wound healing, 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

Compensation: Varies

Number of Visits: 2

Duration: 2-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores various treatments for sebaceous hyperplasia, a skin condition that causes small, harmless facial bumps. Researchers are comparing three treatments: a combination of two lasers (pulsed dye laser and Nd:YAG laser), another laser (Erbium:YAG laser), and a technique called electrodesiccation and curettage, which involves drying and scraping off the bumps. Each participant's bumps will receive two treatments, using different methods on different bumps, to determine the most effective approach. Individuals who have previously received cosmetic treatment for sebaceous hyperplasia and are in good general health, particularly those in the Chicago area, may qualify for this trial. As a Phase 2 trial, this research aims to assess the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this study—electrodessication and curettage (ED&C), Erbium:YAG laser, and PDL plus Nd:YAG laser—have different safety records based on past findings.

Previous studies found that electrodessication and curettage can cause side effects like skin lightening or small scars, though these were rare.

With the Erbium:YAG laser, redness occurred in about half of the cases as the most common side effect. Some people also experienced pain during treatment, while scars and changes in skin color were less common.

The PDL plus Nd:YAG laser combination has been studied less for sebaceous hyperplasia specifically, but other research shows it is generally safe. Possible side effects include temporary redness or swelling.

This trial is in a phase that tests both safety and effectiveness, indicating that the treatments have shown some safety in earlier tests. Participants should consider the benefits and risks based on these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Sebaceous hyperplasia can be tricky to treat, but researchers are excited about using lasers because they offer targeted precision that other methods might lack. Electrodessication and curettage, Erbium:YAG Laser, and the combination of Pulsed Dye Laser with Nd:YAG Laser each bring something unique to the table. The lasers can precisely vaporize or shrink the lesions with minimal damage to the surrounding skin, potentially leading to better cosmetic outcomes and quicker recovery. Additionally, these laser treatments might offer a more consistent and less invasive option compared to traditional methods like topical retinoids or cryotherapy. Overall, the promise of improved results with less downtime is what makes these laser treatments a hot topic in the dermatological community.

What evidence suggests that this trial's treatments could be effective for sebaceous hyperplasia?

Research has shown that electrodessication and curettage, one of the treatments in this trial, effectively treats sebaceous hyperplasia, often outperforming methods like freezing (cryotherapy). The Erbium:YAG laser, another treatment option in this trial, has also achieved success, providing good cosmetic results with few side effects, as reported by past patients. For the PDL plus Nd:YAG laser combination, which is also under study in this trial, studies have reported a high rate of lesion reduction and improved skin appearance, with many lesions either disappearing or becoming much smaller after treatment. Overall, these treatments have effectively managed sebaceous hyperplasia, each showing promise in its own way. ^{1 3 4 6 7}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 in good health living in the Chicago area, seeking cosmetic treatment for sebaceous hyperplasia. They must understand and sign a consent form. Excluded are those with poor wound healing, recent sun exposure affecting skin pigment, pregnant or nursing individuals, and anyone unable to communicate or cooperate due to language barriers or mental impairment.

Inclusion Criteria

Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

I am getting cosmetic treatment for oily skin with bumps.

In good general health as assessed by the investigator

Exclusion Criteria

Subject unwilling to sign an IRB approved consent form

Patient with recent sun exposure that would result in pigment changes at the discretion of the physician

Patient pregnant or nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment for sebaceous hyperplasia with either Erbium:YAG, PDL plus Nd:YAG, or ED&C. Each lesion is treated twice, 2-6 weeks apart.

2-6 weeks

2 treatment sessions

Follow-up

Participants are monitored for changes in lesion size and count 4-12 weeks after the first treatment.

4-12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrodessication and curettage
• Erbium:YAG Laser
• Nd:YAG Laser
• Pulsed Dye Laser

Trial Overview The study compares three treatments for sebaceous hyperplasia: Pulsed Dye Laser (PDL) plus Nd:YAG Laser; Erbium:YAG Laser; and Electrodessication & Curettage (ED&C). Each participant's lesions will be randomly assigned one of these treatments. Lesions get treated twice within 2-6 weeks and results are checked after 4-12 weeks.

How Is the Trial Designed?

Group I: ED&C treatment Active Control 1 Intervention

Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.

Group II: Erbium:YAG Laser Active Control 1 Intervention

Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.

Group III: PDL plus Nd:YAG Active Control 2 Interventions

Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

The Er:YAG laser treatment for acne scars showed a significant average clinical improvement of 50.2% in 128 patients aged 22-42, indicating its efficacy in enhancing skin texture and reducing scarring.

The treatment was found to be safe, with most side effects being mild and temporary; however, some patients experienced prolonged erythema and post-inflammatory hyperpigmentation, which occurred in 7% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. Kutlubay, Z., Gokdemir, G.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11541056/

A Blinded Randomized Clinical Trial Study It appears that electrosurgery is more effective in the treatment of sebaceous hyperplasia, cherry angioma and skin tags, while cryotherapy is more effective ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/86/NCT04539886/Prot_SAP_000.pdf

Clinical Investigational Plan The rationale for this IDE study is to compare the safety and effectiveness of the CellFX System to the comparator group, Electrodessication ( ...

3. researchgate.net researchgate.net/publication/385614118_Evaluation_and_Comparison_of_the_Efficacy_and_Safety_of_Cryotherapy_and_Electrosurgery_in_the_Treatment_of_Sebaceous_Hyperplasia_Seborrheic_Keratosis_Cherry_Angioma_and_Skin_Tag_A_Blinded_Randomized_C

A Blinded Randomized Clinical Trial Study Conclusion It appears that electrosurgery is more effective in the treatment of sebaceous hyperplasia, cherry angioma and skin tags, while ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S019096228580013X

Premature sebaceous gland hyperplasia We present a case of premature sebaceous gland hyperplasia that was successfully treated with isotretinoin.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39512253/

A Blinded Randomized Clinical Trial Study Conclusion: It appears that electrosurgery is more effective in the treatment of sebaceous hyperplasia, cherry angioma and skin tags, while cryotherapy is more ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12461789/

Evaluation of the Efficacy and Safety of Single‐Needle ... This study aimed to evaluate the efficacy and safety of single‐needle radiofrequency for treating facial sebaceous hyperplasia. Methods. A ...

7. journals.lww.com journals.lww.com/dermatologicsurgery/fulltext/2020/06000/safety_and_efficacy_of_nanosecond_pulsed_electric.15.aspx

Safety and Efficacy of Nanosecond Pulsed Electric Field... However, the prevalence of sebaceous hyperplasia has been reported to be as high as 10% to 16% in patients receiving long-term immunosuppression. 1. Traditional ...