Acne Treatment with

AGNES Micro-insulated Needle

RF system

Dr Adam Rish MBBS BMedSc BA(Hons) MFA FACAM FCPCA

and

Dr Gun Young Ahn M.D. Ph.D.

Gowoonsesang Clinic Seoul, Korea.

SPEAKER’S DECLARATION OF INTEREST Expenses to attend LCMC 2016

Registration, accomodation and

social functions paid DC

Conferences

Yes

Director in company associated

with presentation Kosmedical Pty

Ltd importer AGNES RF

Yes

Direct or indirect payment received

from company or organisation

associated with presentation

No

Direct or indirect payment received

from outside organisation or entity

to perform investigation being

presented

No

Past payment for services by

company or organisation

associated with presentation

No

Any other conflict of interest

relevant to the presentation. No

Acne Vulgaris • Self limiting (2-5years), fluctuating disorder pilo-sebaceous units

• Most adolescence F=M (M ++), later due to hormone disturbance

• Teens 20% with FH cf 10% no FH, twins 80% genetic 20% acquired

• Can leave lifelong pitted and/or hypertrophic scars

• May be psychologically disturbing to self-esteem (40% adolescents)

• Mix comedonesA, papulesB, pustulesC and nodulesD

Etiology

• Follicular epidermal hyperproliferation (+adhesion) (blocks gland)

• Excess sebum production (medium for culture bugs)

• Propionibacterium acnes activity (puberty 10/cm2 to 106/cm2 )

• Inflammation (white cells, pus, pigment, scarring)

Etiology • Androgen excess (DHEAS>DHT) in puberty (most normal range)

and menopause. Also androgen syndromes eg PCOS, adrenal hyperplasia and tumours (DHEAS>8000ng/ml)

• Decrease linoleic acid

• Increased interleukin-1

• Increased FGFR-2

Polycystic Ovary Syndrome • PCO 20%, PCOS (no cysts) 6% women

• Acne, hirsute, deeper voice, libido, amenorrhea

• Check Testosterone (>150ng/ml), SHBG, DHEAS, 17OH Progesterone, Prolactin, LH, FSH (LH/FSH >2 diagnostic), BSL

• Rx weight lost, antiandrogens (Spironolactone, Androcur, Cyproterone), Metformin to insulin resistance

• Reassess at 12 months

Clinical Findings

• Gradual onset lesion

• If sudden ?androgenic tumour, PCOS

• Main site face, back chest

• May scar: ice pickA, rollingB, boxcar, hypertrophicC

A B C

Medical Treatment

• Be aggressive enough to prevent scarring

• follicular keratin, sebum, P. acnes, inflammation

• Cleansers - medicated soaps eg pHisohex, Triclosan

• Keratolytics - salicylic acid .5-2%, azaleic acid (Finacea), retinoids

• Antibiotic gels - benzyl peroxide (inactivates retinoids), erythromycin, clindamycin, Bactroban, dapsone 5-7.5% gel

• Oral antibiotics - vibramycin 50mg m, minomycin 100mg bd

• Oral contraceptives +/- antiandrogenic eg Yaz, Diane 35 (DVT)

• Antiandrogens - Spironolactone 50-100mg (need OCP)

• Isotretinoin (Roaccutane) 0.5-1mg/kg/day, 20/52 (need OCP)

Acne

Pre-treatment Post retinal .1%

Roaccutane

• Actions: decrease sebum, seb. gland size, comedogenesis, P. acnes

• Low dose regimes less side effects equal efficacy: 10-20mg/day for 3-5/12 until resolved then 10mg/day for 2-4/12

• Females need negative BHCG, OCP - 1/12 pre. 1/12 post

• Side effects: teratogenic, dryness, blepharitis, alopecia, headache, muscle pain, LFT, hyperlipodaemia, neutropaenia, osteopaenia

• Issue depression hard to assess as in high risk group

• Recurrences common

Roaccutane

• In Australia S4 may be prescribed by GP on PBS but must comply with state laws which all say restricted to dermatologists

• May 2014 RACGP made case for GPs. ACD said bad idea!

• On 4 Corners in 2006 on suicide Campbell Bolton, treated with no GP referral, Dr Stephen Shumack said, “Dermatologists are dermatologists. We’re not specifically trained in assessing mental state of patients”

• In NZ GPs prescribe with no extra problems

• Why not GPs: they know patients, know OCP, and depression and are easy to get in to see (especially rural) and cost less money (? SfX as prescribing as availability)

OTC Medical Treatments

• Cleansers pHisohex, Triclosan soap

• Keratolytics salicylic acid .5-2% azaleic acid (Finacea) .01% tretinoin, retinal (in cosmeceuticals)

• Antibiotic gels - benzyl peroxide (Benzac)

• Hydroquinone 2% (if acne PIH) John Plunkett’s Superfade (with salicylic acid)

Diet • Uncertain link (poor early studies)

• Dairy and high glycaemic foods possible link

• Avoid foods that trigger

• Medications - steroids, phenytoin, lithium, high dose Vitamin B

Surgery

• Medical treatments better active acne as scars

• Don’t squeeze better Comedone remover eg Unna

• Use needle eg 24G to open pore

• Intralesional steroid (trimacinolone 5mg/ml) for nodular acne

• Undermining 19G needle good for scars

• Skin needling eg Dermapen good for scars

Microdermabrasion

Developed Mattioli 1985

Al oxide crystals blast skin, 20-90mmHg

Post 6 Mx

Skin Needling

Developed Des Fernandez

Roller with multiple .25mm needles

8 weeks post 1 Mx

Skin Undermining

6/12 post 3X 19G needle undermining + non ablative 1064nm laser

Chemical Peels Basics

equipment

Cross technique 100% TCA

Phototherapy • UV light beneficial (70% better in summer (?camouflage effect) • UVB kills P. acnes but poorly penetrates skin • UV 2x weekly helps but skin cancer • Phototherapy uses endogenous porphyrins or exogenous

(eg aminolevulinic acid (ALA) ) • Narrowband blue light (407-420nm) plus red light (goes deeper)

15 min, twice weekly, on face 4/52 - 60% lesions in 80% patients

Lasers and IPL

• KTP 532 nm 36% in acne when used twice weekly for 2 weeks

• IPL (400nm filter), Lasers of 1064nm, 1320nm and 1450nm can reduce active lesions with multiple treatments

• Nd:Yag 1064 at low fluence can reduce acne scarring

• Ablative lasers eg Fractionated erbium and CO2 remodel scars

Clinipro fractional CO2 Pre and post fractionated CO2 resurfacing

Efficacy YAG 1064nm and 1320nm

Lots of studies for 1064nm (107 Derm Surg) • Nonablative Acne Scar Reduction after a Series of Treatments with a Short-Pulsed 1,0

64-nm Neodymium:YAG Laser GRAEME M. LIPPER MD1,2, MARITZA PEREZ MD1,2,3

Dermatologic Surgery Volume 32, Issue 8, August 2006 = both effective YAG better

• Non-ablative subsurface remodelling: Clinical and histologic evaluation of a 1320-nm

Nd:YAG laser

Journal of Cosmetic and Laser Therapy 1999, Vol. 1, No. 3 , David J Goldberg

Clinipro 1064/1320nm Nd:YAG

Clinical-Lucas-Plus Q-Switched Nd:YAG

Reduced solar elastosis: Increased Collagen

Pre Post

Dermatol Surg 27:8:August 2001 Goldberg and Silapunt: q-switched nd:yag laser for wrinkles

Mode of Action

• Uncertain

• Results at 1 hr direct heating effect = ?oedema

• Longer effects as increased collagen stimulation

• Skin at 47C for 20 min burns

• Q Switch no heat damage as such a fast temperature rise - but skin “thinks” it is burnt and releases heat shock proteins causing remodelling

• Low fluence 3+J/cm2 comfortable and results

• Like flicking a switch above a threshold pushing harder does not make the light turn on better

Treatment modalities for acne

Temporary Methods

1. Topical agents

2. Oral medications

3. Medical skin cares

4. Chemical peelings

5. Lasers

6. PDT

Permanent Methods

1. AGNES (Selective sebaceous gland destruction, Kobayashi method)

AGNES

Handpieces for acne Tx for melting & skin tightening

Micro-insulated Needles

Acne

Syringoma

Blackhead

Eye bag

Wrinkle

No sebaceous gland, no acne

Destroy the sebaceous gland

without epidermal burn = SSGD

Selective Sebaceous Gland Destruction

Should I destroy every sebaceous gland?

No.

“Acne usually relapses from the same follicles”

“Of 200,000 pilosebaceous units on face less than 10% acne prone”

Acne prone follicles

narrow area of the infundibulum

vulnerable to obstruction with androgenic stimulation

severe inflammation of the infundibulum

scarring as a sequela.

Distance from surface to SG 500μ

400 Mm

500~600 Mm

Hair follicle with Normal sebaceous gland

(normal)

Conditions for Selective Sebaceous Gland Destruction

1. Protect 400 Mm

The distance from skin surface to sebaceous gland should be

insulated

2. Non-insulated part should be longer than 1000 Mm (1mm)

As sebaceous hyperplasia in acne

3. RF energy should increase the temperature over than 70 °C

sebaceous gland is a kind of fatty tissue

4. Minimal damage to surrounding tissues

High peak power with short pulse duration

Square pulse > Sign wave form

Fat tissue has low conductivity

Reaching to the melting point of fatty tissue needs about 10 times higher than wet skin.

Partially insulated microneedle of AGNES

Stopper

Partially insulated micro-needle

AGNES TEST

Insulated Non-insulated

Easy checking of insulation status

Studies

Normal human sebaceous gland

Animal study

Clinical study

International J. Dermatol. 2012. 51. 339-344

Selective sebaceous gland electrothermolysis as a treatment for acne: a prospective pilot study

Gun Young Ahn, In Woong Lee, Beom Joon Kim, Myeung Nam Kim, Hiromi Aso

Materials for prospective study

• Patients

– Twelve patients with moderate to severe facial acne

– 6 males and 6 females, ages from 20 to 32 years (24.6±3.4)

– Fitzpatrick type III-V

– No medications, no peelings during the study

– Exclusion criteria for candidates

• Oral antibiotics or isotretinoin within previous 6 months

• Use of topical or antibiotics or retinoids within previous 2 weeks

• Oral contraceptive with anti-androgenic properties less than 12 weeks

• Pregnancy and lactation in female patients

Methods

• Procedure

– Application of topical anesthetic cream prior to procedure

– Identifying acne lesions

– High frequency current was applied for 0.12 to 0.50 seconds at an intensity of approximately 40W

– The next day or the day after following the procedure, the contents of lesions were eliminated by acne extractor with gentle pressure

– Total 3 sessions of treatments were performed for 1~3/12 intervals

Methods • Evaluation

– Before and after each treatment session, 1 month and 1 year after the final treatment

• Overall success rate (Investigator’s global severity assessment)

– Clear or almost clear

• No. of lesions

– Photo

– Inflammatory and non-inflammatory lesion

• Adverse events

• Patients’ satisfaction score

– 4, very satisfied; 3, satisfied; 2, slightly satisfied; 1, unsatisfied

Results

• Overall success rate

– All patients (100%) were Grade 0 or 1 (at 1 month after the final

treatment)

Rating Definition

0 - Clear Residual hyperpigmentation and erythema may be present

1 - Almost clear A few scattered comedones and a few (less than five) small papules

2 - Mild Easily recognizable; less than half the face is involved. Many comedones and

many papules and pustules

3 - Moderate More than half of the face is involved. Numerous comedones, papules

and pustules

4 - Severe Entire face is involved. Covered with comedones, numerous papules and pust

ules and few nodules and cysts

5 - Very severe Highly inflammatory acne covering the face; with nodules and cysts

present

* Investigator’s global severity assessment (IGA)

Results • Lesion counts (inflammatory and non-inflammatory acne)

– 61.1% (1st) 82.2% (2nd) 96.3% (3rd) reduction in inflammatory lesions

– 49.3% (1st) 69.0% (2nd) 83.3% (3rd) reduction in non-inflammatory lesions

Inflammatory lesions Non-inflammatory lesions

Results Patients’ satisfaction score

– 3.50±0.67

Adverse events

– Transient erythema at the treated site; most common

– No other severe adverse events

Relapse: 2 of 12 patients at 1 year after last treatment

– Mild acne

Slightly satisfied, 8

(1)

Satisfied, 33 (4)

Very satisfied, 59

(7)

Unsatisfied, 0

Slightly satisfied

Satisfied

Very satisfied

Unsatisfied

Conclusion

1. Long-term cure rate & low recurrence rate for acne

2. Only 3 times of Tx. are needed in most of patients.

3. Solution for acne patient who does not want oral medication

4. No systemic side effect

5. Initial training is important

6. No facial dryness (not as in PDT, isotretinoin)

Protocol for SSGD

Step 1. Empty the hair follicles.

– Complete extraction of sebum using acne

extractor by nurse

Step 2. Destroy the sebaceous glands.

– using microinsulated needle by doctor

Step 3. Removal of debris & exudates

- within 3 days by nurse

Step 1. Empty the hair follicles.

- by Nurse/Aesthetician

Step 1. Empty the hair follicles.

1. Wearing the magnifying loupe.

2. Making the hole with 21G needle with proper direction.

3. Extraction with gentle pressure with Unna comedone

remover.

Pucture technique

Good Bad

Step 2. Destroy the sebaceous glands.

- by Doctor

Inflammatory acnes

Acne Treatment by AGNES

Step 3. Removal of debris & exudates within 3 days

- by Nurse/Aesthetician

1. Melting the debris of seb. gl. for reduce the pain while extraction

2. Promoting wound healing by bipolar energy

–> collagen remodeling

Clinical Photos (long term follow up)

22/F Before 3 month after the 1st Treat. 1 month after the 1st Treat.

1 year after the 1st Treat. & Before the 2nd Treat.

6 month after the 1st Treat. 6 month after the 2nd Treat.

AGNES AGNES AGNES

AGNES AGNES AGNES

8 month after the 1st Treat. & Before the 2nd Treat

F/25 Before 6 month after the 2nd Treat.

AGNES AGNES AGNES

F/27 Before 5 month after the 2nd Treat. & Before the 3rd Treat

2 month after the 1st Treat. & Before the 2nd Treat

4 month after the 3rd Treat. & Before the 4th Treat.

AGNES AGNES AGNES

AGNES

1 month after the 1st Treat. & Before the 2nd Treat

Immediate after

2 month after the 3rd Treat. & Before the 4th Treat.

1 month after the 2nd Treat. & Before the 3rd Treat

F/29 Before

AGNES AGNES AGNES

AGNES AGNES

F/30 Before 6 month after the 2nd Treat. 2 month after the 1st Treat.

& Before the 2nd Treat

2 year after the 2nd Treat. & Before the 3rd Treat.

15 month after the 2nd Treat.

AGNES AGNES AGNES

AGNES AGNES

F/30 Before 4 month after the 2nd Treat.

1 month after the 1st Treat. & Before the 2nd Treat

1 year after the 2nd Treat. & Before the 3rd Treat.

8 month after the 2nd Treat. 9 month after the 3rd treat.

AGNES AGNES AGNES

AGNES AGNES AGNES

Before

Indications

1. For Sebaceous gland disorders

– Acne

2. For Eccrine gland disorder

– Syringoma

3. For Wrinkle

– Periorbital

– Perioral

4. For Eye Bag (Infraorbital fat herniation)

5. For Scar

- Deep ice-peak type scars, smallpox scars

6. For Double chin

For deep scars

No down time

No redness

No scabs

5 mo. After 1st session Smallpox scar (before)

Smallpox scar (before) 6 mo. After 2nd session

Syringomas treated by intralesional insulated needles without epidermal damage

Ann Dermatol. 2010 August; 22(3): 367–369.

Before

3 mo. after 2 sessions

For eye bags

3/7 down time

with redness and swelling

May need LA - bruise

Before

Before

For fine wrinkles

1/7 down time

with redness

Thank you