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DENVER – Combining according to Jill S. Waibel, MD.
“Why do we need lasers and light for acne? We have compliance issues, particularly in the pubertal population,” she said at the annual conference of the American Society for Laser Medicine and Surgery. “We also have systemic side effects from medications and antibiotic resistance. Acne is still the number one reason people see a dermatologist.”
The gold microparticles were cleared by the Food and Drug Administration in September 2018 for the treatment of mild to moderate inflammatory acne. Based on European study data and ongoing studies in the United States, the optimal treatment approach begins with putting on a topical retinoid nightly and benzoyl peroxide (BPO) wash to clear follicular debris and reduce bacterial load prior to the application of gold microparticles and laser energy.
Dr. Waibel, director of the Miami Dermatology and Laser Institute, presented results from a clinical trial of 64 patients with mild to moderate acne that was conducted at seven European centers. All patients applied topical 0.1% adapalene/2.5% benzoyl peroxide daily for 2-4 weeks, then they underwent three microparticles plus laser procedures over a 2-week period. “It takes about 10 minutes to put the gold nanoparticles on,” Dr. Waibel said. “They’re rubbed in by a massager, the particles get in down into the follicle. Once it’s in the follicle, you wipe the gold completely off and you activate the FDA-approved 1064 nm Nd:YAG laser.”
Energy was delivered at a fluency of 25-34 J/cm2 and a pulse duration of 30 seconds. Concomitant rescue medications were allowed at the discretion of the investigator after the 2-month evaluation. Formal evaluations included inflammatory lesion counts at baseline, 2, 3, and 6 months; the Investigator Global Assessment scale at baseline, 2, 3, and 6 months; and safety and tolerability. Most of the patients (78%) were female, and their average age was 23 years, with a range between 13 and 38 years. The average level of pain reported by patients was 4 on a scale between 0 and 10, and mild, transient erythema and edema were reported post procedure. There were no adverse events otherwise.
Dr. Waibel reported that the interim mean improvement of inflammatory lesion counts was 66% at 3 months and 79% at 6 months. “At six months, 63% of patients were clear or almost clear according to the Investigator Global Assessment scale,” she added.
After the three treatment sessions, researchers observed a 63% reduction in acne at 2 months, a 74% reduction at 6 months, and an 85% reduction at 12 months. By comparison, a subset of 26 patients who received gold microparticle monotherapy had a 49% reduction in acne at 2 months and a 65% reduction at 6 months.
“A short course of retinoid and benzoyl peroxide prior to gold microparticles treatment improved the inflammatory lesion count reduction, compared with historical studies,” Dr. Waibel said (J Invest Dermatol. 2015;135[7]:1727-34). “Gold microparticles treatment for acne may be part of a multitherapy approach for patients with mild to moderate facial acne. Clinical outcomes are predictable and durable through 12 months.”
The approach is being further studied in the United States and researchers are exploring the potential for fewer treatments over a period of two weeks. Dr. Waibel disclosed that she has served on the advisory board for Sebacia, which developed the gold microparticles, and has received clinical trials funding from the company. She also reported having financial relationships with numerous other device and pharmaceutical companies.
DENVER – Combining according to Jill S. Waibel, MD.
“Why do we need lasers and light for acne? We have compliance issues, particularly in the pubertal population,” she said at the annual conference of the American Society for Laser Medicine and Surgery. “We also have systemic side effects from medications and antibiotic resistance. Acne is still the number one reason people see a dermatologist.”
The gold microparticles were cleared by the Food and Drug Administration in September 2018 for the treatment of mild to moderate inflammatory acne. Based on European study data and ongoing studies in the United States, the optimal treatment approach begins with putting on a topical retinoid nightly and benzoyl peroxide (BPO) wash to clear follicular debris and reduce bacterial load prior to the application of gold microparticles and laser energy.
Dr. Waibel, director of the Miami Dermatology and Laser Institute, presented results from a clinical trial of 64 patients with mild to moderate acne that was conducted at seven European centers. All patients applied topical 0.1% adapalene/2.5% benzoyl peroxide daily for 2-4 weeks, then they underwent three microparticles plus laser procedures over a 2-week period. “It takes about 10 minutes to put the gold nanoparticles on,” Dr. Waibel said. “They’re rubbed in by a massager, the particles get in down into the follicle. Once it’s in the follicle, you wipe the gold completely off and you activate the FDA-approved 1064 nm Nd:YAG laser.”
Energy was delivered at a fluency of 25-34 J/cm2 and a pulse duration of 30 seconds. Concomitant rescue medications were allowed at the discretion of the investigator after the 2-month evaluation. Formal evaluations included inflammatory lesion counts at baseline, 2, 3, and 6 months; the Investigator Global Assessment scale at baseline, 2, 3, and 6 months; and safety and tolerability. Most of the patients (78%) were female, and their average age was 23 years, with a range between 13 and 38 years. The average level of pain reported by patients was 4 on a scale between 0 and 10, and mild, transient erythema and edema were reported post procedure. There were no adverse events otherwise.
Dr. Waibel reported that the interim mean improvement of inflammatory lesion counts was 66% at 3 months and 79% at 6 months. “At six months, 63% of patients were clear or almost clear according to the Investigator Global Assessment scale,” she added.
After the three treatment sessions, researchers observed a 63% reduction in acne at 2 months, a 74% reduction at 6 months, and an 85% reduction at 12 months. By comparison, a subset of 26 patients who received gold microparticle monotherapy had a 49% reduction in acne at 2 months and a 65% reduction at 6 months.
“A short course of retinoid and benzoyl peroxide prior to gold microparticles treatment improved the inflammatory lesion count reduction, compared with historical studies,” Dr. Waibel said (J Invest Dermatol. 2015;135[7]:1727-34). “Gold microparticles treatment for acne may be part of a multitherapy approach for patients with mild to moderate facial acne. Clinical outcomes are predictable and durable through 12 months.”
The approach is being further studied in the United States and researchers are exploring the potential for fewer treatments over a period of two weeks. Dr. Waibel disclosed that she has served on the advisory board for Sebacia, which developed the gold microparticles, and has received clinical trials funding from the company. She also reported having financial relationships with numerous other device and pharmaceutical companies.
DENVER – Combining according to Jill S. Waibel, MD.
“Why do we need lasers and light for acne? We have compliance issues, particularly in the pubertal population,” she said at the annual conference of the American Society for Laser Medicine and Surgery. “We also have systemic side effects from medications and antibiotic resistance. Acne is still the number one reason people see a dermatologist.”
The gold microparticles were cleared by the Food and Drug Administration in September 2018 for the treatment of mild to moderate inflammatory acne. Based on European study data and ongoing studies in the United States, the optimal treatment approach begins with putting on a topical retinoid nightly and benzoyl peroxide (BPO) wash to clear follicular debris and reduce bacterial load prior to the application of gold microparticles and laser energy.
Dr. Waibel, director of the Miami Dermatology and Laser Institute, presented results from a clinical trial of 64 patients with mild to moderate acne that was conducted at seven European centers. All patients applied topical 0.1% adapalene/2.5% benzoyl peroxide daily for 2-4 weeks, then they underwent three microparticles plus laser procedures over a 2-week period. “It takes about 10 minutes to put the gold nanoparticles on,” Dr. Waibel said. “They’re rubbed in by a massager, the particles get in down into the follicle. Once it’s in the follicle, you wipe the gold completely off and you activate the FDA-approved 1064 nm Nd:YAG laser.”
Energy was delivered at a fluency of 25-34 J/cm2 and a pulse duration of 30 seconds. Concomitant rescue medications were allowed at the discretion of the investigator after the 2-month evaluation. Formal evaluations included inflammatory lesion counts at baseline, 2, 3, and 6 months; the Investigator Global Assessment scale at baseline, 2, 3, and 6 months; and safety and tolerability. Most of the patients (78%) were female, and their average age was 23 years, with a range between 13 and 38 years. The average level of pain reported by patients was 4 on a scale between 0 and 10, and mild, transient erythema and edema were reported post procedure. There were no adverse events otherwise.
Dr. Waibel reported that the interim mean improvement of inflammatory lesion counts was 66% at 3 months and 79% at 6 months. “At six months, 63% of patients were clear or almost clear according to the Investigator Global Assessment scale,” she added.
After the three treatment sessions, researchers observed a 63% reduction in acne at 2 months, a 74% reduction at 6 months, and an 85% reduction at 12 months. By comparison, a subset of 26 patients who received gold microparticle monotherapy had a 49% reduction in acne at 2 months and a 65% reduction at 6 months.
“A short course of retinoid and benzoyl peroxide prior to gold microparticles treatment improved the inflammatory lesion count reduction, compared with historical studies,” Dr. Waibel said (J Invest Dermatol. 2015;135[7]:1727-34). “Gold microparticles treatment for acne may be part of a multitherapy approach for patients with mild to moderate facial acne. Clinical outcomes are predictable and durable through 12 months.”
The approach is being further studied in the United States and researchers are exploring the potential for fewer treatments over a period of two weeks. Dr. Waibel disclosed that she has served on the advisory board for Sebacia, which developed the gold microparticles, and has received clinical trials funding from the company. She also reported having financial relationships with numerous other device and pharmaceutical companies.
REPORTING FROM ASLMS 2019