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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare treatment of sebaceous hyperplasia with pulsed dye laser (PDL) plus neodymium doped yttrium aluminum garnet laser (Nd:YAG) versus erbium doped yttrium aluminum garnet (erbium:YAG) laser versus electrodesiccation and curettage (ED\&C). This is a randomized clinical trial. Approximately 18 participants will enrolled. Each participant will have their sebaceous hyperplasia lesions randomized to receive either Erbium:YAG, PDL plus Nd:YAG, or ED\&C treatment. Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Lesions will be treated twice, 2-6 weeks after the first treatment. Lesion size and count will be measured before treatment and at follow-up 4-12 weeks after the first treatment. This study is a pilot study designed to determine the feasibility of these procedures. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment for sebaceous hyperplasia?

Research shows that the pulsed-dye laser can successfully treat sebaceous hyperplasia by targeting the blood vessels in the lesions. Additionally, the erbium:YAG laser has been effective in treating various facial skin conditions, including sebaceous hyperplasia, with good cosmetic results. ^{1 2 3 4 5}

Is the Erbium:YAG laser treatment safe for humans?

The Erbium:YAG laser is generally considered safe for treating various skin conditions, as it allows precise removal of skin layers with minimal damage and scarring. Studies have shown good healing and cosmetic results in patients, indicating its safety in humans. ^{1 3 6 7 8}

How does the laser treatment for sebaceous hyperplasia differ from other treatments?

The laser treatment for sebaceous hyperplasia is unique because it uses specific types of lasers, like the pulsed-dye laser and Erbium:YAG laser, to target and shrink the sebaceous glands (oil-producing glands) without causing significant damage to surrounding skin. This approach is non-invasive and can provide precise treatment with minimal scarring, making it a promising option compared to traditional methods like electrodessication and curettage. ^{3 4 5 9 10}

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

2940-nm erbium:YAG laser versus 980-nm diode laser in the treatment of multiple seborrheic keratoses: A prospective comparative randomized study. [2022]

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

Treatment of sebaceous hyperplasia with a novel 1,720-nm laser. [2012]

3. Germany pubmed.ncbi.nlm.nih.gov

[Controlled cosmetic dermal ablation in the facial region with the erbium:YAG laser]. [2019]

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

Elucidating the pulsed-dye laser treatment of sebaceous hyperplasia in vivo with real-time confocal scanning laser microscopy. [2007]

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

Pulsed-dye laser for treating ecchymoses after facial cosmetic procedures. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. [2022]

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

Pulsed 2.94-microns erbium-YAG laser skin ablation--experimental results and first clinical application. [2019]

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

The use of the erbium:YAG laser for the treatment of class III rhytids. [2019]

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

Pulsed Erbium:YAG laser ablation in cutaneous surgery. [2012]

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

Evaluation of the clinical efficacy of the 1,450 nm laser in acne vulgaris: a randomized split-face, investigator-blinded clinical trial. [2015]