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Radiesse study on atrophic acne scarring

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This paper by Dr. Patrick Treacy Medical Director Ailesbury Clinics Ltd. sought to establish the efficacy and safety profile the dermal filler, calcium hydroxylapatite filler in the treatment of …

This paper by Dr. Patrick Treacy Medical Director Ailesbury Clinics Ltd. sought to establish the efficacy and safety profile the dermal filler, calcium hydroxylapatite filler in the treatment of atrophic acne scars. Forty two subjects with differing degrees of atrophic acne scars were treated with this filler over an eighteen month period and the results are published below

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  • 1. | dermatology | peer-reviewdermal fillertreatmentFor atrophicacne scarringPatrick Treacy presents the results of a studyinvestigating the efficacy of dermal fillers in thetreatment of atrophic acne scarringABSTRACT acne scarring were treated with Eleven hyaluronic acid patientsFull title the CaHA filler over a 12‑month (85% of total) showed a 0–25%Problems encountered using period. Thirteen patients were improvement in treateddermal fillers, particularly treated with low molecular atrophic scars at 12 months.calcium hydroxylapatite, as a weight cross-linked hyaluronictreatment in acne scarring. acid in a comparative study. Conclusions Dermal fillers, especiallyObjectives Results CaHA, can provide a safe andThis article aims to establish Most atrophic acne scars efficacious method of treatingthe efficacy and safety profile of responded well to CaHA dermal atrophic acne scars. Thisdermal fillers, especially calcium filler treatment. Icepick scars compound appears to providehydroxyapatite (CaHA) in the were not treated. At 12-month a longer-lasting effect owingtreatment of atrophic acne evaluation, 22% of subjects to volume replenishment andscars. showed a 75% improvement, possible neocollagenesis. The Dr Patrick Treacy is while 48% showed a 50% efficacy of hyaluronic acid in Medical Director of AilesburyMethods improvement. This compared repairing atrophic acne scars is Clinics Ltd and Ailesbury HairTwenty-seven subjects with to an average 0% improvement not demonstrable. Clinics Ltd; Chairman of thediffering degrees of atrophic for the hyaluronic acid cohort. Irish Association of Cosmetic Doctors and Irish RegionalA Representative of the British Association of Cosmetic cne occurs in inhibition, unhappiness, anxiety, and Doctors; European Medical approximately 95% of even suicidal thoughts as a result of their Advisor to Network Lipolysis 16–17-year-old boys and facial appearance5. and the UK’s largest cosmetic website Consulting Rooms. He 84% of 16–17-year-old practices cosmetic medicine girls1. Although the Background in his clinics in Dublin, Cork, London and the Middle East condition usually For many years different treatmentresolves by the mid‑20s, 1% of men and modalities have been used for the revision email: ptreacy@gmail.com5% of women still bear the signs of of atrophic acne scarring, with varyingmoderately severe acne scarring at degrees of success. Many40  years of age2. Some studies show controlled trials have Affectedscarring of some degree may affect up to demonstrated that moderate to95% of patients with acne3. The same severe atrophic acne scars can patients report morestudy found that keloidal or hypertrophic be safely improved through social inhibition,truncal scarring were more common in ablative fractional CO2 laser unhappiness,men. This form of scarring is usually resurfacing (fractional laser skintreated by using such measures as resurfacing; FLSR)6. Although anxiety, and evenintralesional steroids, silicone sheeting, FLSR is still the most popular suicidal thoughts asor vascular laser treatment. Atrophic therapeutic modality for the a result of their facialscarring will often appear many years correction of acne scars, it is not appearance. Keywordslater, and can cause great distress in always effective in all types of calcium hydroxyapatite,patients during their courtship years4. atrophic lesions  — the more common 7 hyaluronic acid, acne scars,Affected patients report more social type of defects encountered after dermal fillers prime-journal.com | March 2013 ❚ 41
  • 2. peer-review | dermatology | Table 1 Four-point grading scale for acne scars Figure 1 Acne scar subtypes Grade 1 Macular Icepick Rolling Boxcar Erythematous, hyper-, or hypopigmented marks Skin surface Grade 2 Mild disease Mild atrophy, can be covered with make-up of facial hair Grade 3 Moderate disease Moderate scarring, not covered by make-up, but can Scar edges be flattened by manual stretching of the skin Grade 4 Severe disease Scarring not flattened with manual stretching Fascia of the skin inflammatory acne. The use of higher energy levels found in the human body as a constituent of bone andmight have improved the results, and also possibly teeth. The CaHA microspheres (25–45 µ) are suspendedinduced significant adverse effects7. Over the past decade, in an aqueous carboxymethylcellulose carrier gel,non-ablative laser resurfacing8–10, radiofrequency (RF)11, composed of cellulose, glycerin, and sterile water. Noneand microneedling12 have been shown to create some of these materials should elicit a chronic inflammatory,improvement in the appearance of these atrophic scars. A infectious or immune response. Multiple clinical andnumber of autologous and non- histologic studies have tended to documentautologous techniques attempting its safety, efficacy, and longevity in tissue17, 18.dermal and subcutaneous augmentation By its very composition, CaHA is By its very composition, CaHA is designedhave been tried to improve the facial designed to provide immediate to provide immediate correction andaesthetic appearance. The autologous correction and long‑term long‑term biostimulatory neocollagenesis.methods have included dermal grafting, Over time, the gel is absorbed, fibroblasts biostimulatory neocollagenesis.fat transfer13, 14, and implantation of appear and the process of neocollagenesisautologous fibroblasts, such as Isolagen®15. begins, stimulating the gradual growth of the There has been interest in non-autologous patient’s own collagen. The carboxymethylcellulose gelaugmentation by way of injections of hyaluronic acid carrier volumises the ‘lost’ space and acts as a replacement(HA), polymethylmethacrylate microspheres (PMMA), filler; the microspheres stimulate neocollagenesis so that,and calcium hydroxylapatite (CaHA)16, 17. CaHA, the main as the gel dissipates, the spheres anchor into the softmineral component of Radiesse® (Merz Aesthetics, San tissue. There, they serve as a scaffold for new collagenMateo, CA), is a synthetic analogue of the inorganic salt growth as early as 4 weeks post-injection, and then continue for up to at least 12 months17, 18. CaHA is not permanent, however. The CaHA microspheres are metabolised into calcium and phosphate ions through normal metabolic processes over 24 months. CaHA will not promote osteogenesis in soft tissues, does not migrate, and does not obscure diagnostic x-rays. The use of dermal fillers At the present time, the use of CaHA is approved by the Food and Drug Administration (FDA) for the correction of moderate to severe facial wrinkles and folds19, 20. CaHA also gained prominence during the period in which dermal fillers were being used for antiretroviral-induced facial lipoatrophy21, 22. It is known to cause persistent nodules in a small percentage of people, especially if it is injected into the vermillion border of the lips23. As many studies have established the biocompatibility and safety Figure 2 17-year-old male of CaHA in facial filling techniques21, the product has patient (A, B, C) before gained popularity in the US and Europe for this indication, treatment with Radiesse, and (D, E) immediately and more recently in the treatment of acne scarring24. after treatment. 1.3 ml HA has been used in aesthetic medicine for a long CaHA was used time, and has an extended safety profile. In its natural42 ❚ March 2013 | prime-journal.com 13021
  • 3. | dermatology | peer-review Soft tissue filler use for acne scarring would be an attractive option to most practitioners as they require little invasive technique. form HA has a short duration time in the tissue, owing skin surface and its sharp edges manoeuvred under the to enzymatic degradation and free radical metabolisation. defect to make subcuticular cuts or ‘cisions’. The principle To avoid these effects, HA gel is modified through of this procedure is to break the fibrotic strands, which cross‑linking to form a water-insoluble polymer hydrogel, tether the scar to the underlying subcutaneous tissue. more resistant to degradation, but with a similar The depression is lifted by the releasing action of the biocompatibility as non-modified HA. Based on the procedure, as well as from connective tissue that forms experience of other authors, many of the available HA during the course of normal wound healing28. preparations are too short-lived (approximately 3–6 months24, 25 to appropriately treat moderate to severe Methods acne scars) and use of such products for this purpose A series of 27 patients (17 male, 10 female; skin phototypes would require a significant total injection volume over I–IV), with varying degrees of atrophic acne scarring, time, with frequent re-treatments, contributing to a Figure 3 23-year-old were treated in a single-centre, prospective, controlled female patient (A) during greater total cost and time commitment for the patient. treatment with Radiesse, study over a 1-year period. Patients were randomly More viscous forms of HA, such as Perlane® (Medicis and (B) 2 weeks after selected on the basis that they did not want to present for Aesthetics, Inc., Scottsdale, AZ) or Juvéderm® Voluma treatment laser resurfacing as a treatment for their problem. This (Allergan, Inc., Santa Barbara, CA), may be appropriate for patients with atrophic scars. The ideal filler for this purpose would be long-lasting, biocompatible, and would not elicit further inflammation or granuloma formation in skin already damaged by acne26. Soft tissue filler use for acne scarring would be an attractive option to most practitioners as they require little invasive technique and could be used in combination with other treatment modalities, such as microneedling or laser resurfacing. Although studies have shown that HA injections do stimulate collagen formation in the short term, this effect is probably more related to the physical act of injection, rather than to the HA itself. Subcision is a term introduced by Orentreich and Orentreich27 to describe the minor surgical procedure for treating depressed acne scars and wrinkles, using a hypodermic needle inserted through a puncture in the3 10:38 prime-journal.com | March 2013 ❚ 45
  • 4. | dermatology | peer-review being agreed between patient and physician. It was decided not to record the amount of product used as this was not felt to be contributory to the final result. Histologic evaluation of cutaneous biopsies were not obtained before or during treatment, although it was offered to at least one of the patients who had a resultant adverse reaction. Betadine® cleansing was used in most patients and doxycycline 100 mg for 2 days was given as prophylaxis in 11 patients, who were felt to be at risk of infection as they still seemed to have active acne. One patient, who had a previous photoallergic reaction to doxycycline, was prescribed Augmentin-Duo twice daily for 2 days. Subjects were not excluded from the study on the basis of bleeding disorders or whether they were taking anticoagulants/anti-inflammatory agents, as it was felt that while the bruising may be unsightly, it would likely meant the patients were enrolled sporadically, rather improve overall healing. Patients who had receivedthan entering the study at the same time. The subjects Figure 4 23-year-old male synthetic collagen, HA, PMMA, CaHA, or autologousranged in age from 16–63  years, and all acne scarring patient (A) before treatment fibroblast injections to treated areas within the previous 6 with Radiesse, and (B)severity scores fell between 4 and 30 on the Goodman months were excluded from the study. Clinical 2 weeks after treatmentsystem (Table  1). Patients were also evaluated using assessment scores were determined at each treatmentdigital photography and an improvement graduation session and follow-up visit. Patient satisfaction surveysscale at each subsequent treatment visit, at 1, 3, 6, 12 and and digital photography were used where they were24 months post-procedurally: appropriate to both parties, although both were■■ 0 = no improvement considered subjective, with patients tending to focus on■■ 1 = 0–25% improvement the smallest detail and physicians photographically■■ 2 = 25–50% improvement favouring the better results. All patients were reviewed at■■ 3 = 50–75% improvement 2 or 4 weeks post‑treatment for a top-up of Radiesse, if■■ 4 = 75–100% improvement required. It was noted that 17 patients■■ 5 = 100% improvement. Subscision of each required a top-up of at least 0.15 ml CaHA at Multiple acne scar grading classification systems of atrophic scar was one of the first two visits. Smaller amountsvarying complexities have been introduced. The most performed 1 week prior to (< 0.1 ml) were not recorded, as it was feltbasic, practical system divides atrophic acne scars into that the patient may have seen somethree main types: icepick, rolling, and boxcar scars29 injection with CaHA to defects under deeper scrutiny that were(Figure 1). It is common for patients to have more than one give a more uniform initially missed during the procedure.type of scar. aesthetic effect. A series of 13 patients (7 male, 6 female; skin phototypes I–IV) with varying degreesTreatment of atrophic acne scarring were treated in a similar mannerSubscision of each atrophic scar was performed 1  week with low molecular weight cross-linked HA, and monitoredprior to injection with CaHA to give a more uniform over a 12‑month period. Patients were randomly selectedaesthetic effect. Radiesse was injected using a 27  gauge on the basis that they did not want to present for laserneedle into the space left after subscision of the acne scar resurfacing as a treatment for their problem.in the region of the mid- to deep dermis, although final Figure 5 26-year-old oldplacement also depended on the presence of fibrous and male patient (A) before Resultscystic tissue in this region of the skin. The total volume of treatment with CaHA and Twenty-seven patients entered this 12-month study.CaHA used varied with each patient, with an end-point (B) 4 weeks after treatment Moderate to excellent clinical improvement was prime-journal.com | March 2013 ❚ 47
  • 5. peer-review | dermatology |observed after 4 weeks in almost all of the patients 4, of Asian origin) with minimally active acne on astudied (20 patients with score 4, 75–100%; six patients Key points previous trial developed cellulitis and laterwith score 3, 50–75%). One patient had score 1, 0–25% desquamation.improvement, while no subjects scored either 0 or 5. At n Although fractional laser skin resurfacing isthe 6-month assessment 12 patients (44% of total) had still the most popular Discussionscore 4 (75–100% improvement) and 11 patients (40%) had therapeutic modality There are many methods that can be used in thescore 3 (50–75% ). At 12-month evaluation, six patients for the correction of treatment of atrophic acne scarring. Most tend to(22%) showed 75% improvement; 14 patients (48%) showed acne scars, it is not replace the volume lost by the atrophic effects of the always effective in allbetween 50% improvement, and five patients (18%) types of atrophic acne. Newer injectable fillers are biocompatible andshowed a 25% improvement in treated atrophic scars. lesions safer, and can provide an alternative means of treating Thirteen patients entered the 12-month HA study. n Soft tissue filler use acne scarring in patients not opting for laser resurfacing.Moderate-to-excellent clinical improvement was observed for acne scarring would The author has used the HA-based filler Matridex®after the initial treatments in almost all of the HA patients be an attractive option (BioPolymer GmbH & Co., Germany), CaHA, and thestudied At 4-week assessment, nine patients still showed to most practitioners, as polyalkylimide Bio-Alcamid® (Polymekon, Brindisi, they require littlemoderate-to-excellent results, but this had fallen off invasive technique and Italy) for this purpose over the years. Some of thesedramatically at 3-month assessment: only two patients could be used in fillers simply provide a physical filling effect, whilehad score 4 (75–100% improvement) and two patients (23% combination with other others induce a delayed collagen stimulatory effect (e.g.of total) had score 3 (50–75% improvement). At 6-month modalities, such as CaHA and poly-L-lactic acid). An ideal fillingevaluation, 12 patients (92%) showed a 0–25% improvement. microneedling or laser agent should restore atrophic volume and stimulate resurfacing The author felt both of the dermis to synthesise new collagen for a long‑lasting n Many studies havethe fillers initially provided CaHA is established the effect.a simple physical biocompatibility and Based on the experience of this study, the author feelsvolumising effect. There biosynthetically safety of CaHA in facial CaHA is a suitable product for this purpose, showing awas a longevity associated produced and filling techniques. The clearly demonstrable benefit still present at 6–12 months. product has gainedwith the therapeutic effect does not elicit popularity in the US and A comparative study performed with HA preparationsof the calcium showed the compound was not of medical or commercialhydroxylapatite (CaHA), a chronic Europe for this benefit to either the physician or patient, with most of the indication, and moreprobably secondary to the inflammatory recently in the product disappearing at only 6–12  weeks. More viscousduration of the filler and or immune treatment of acne scarring forms of HA, such as HyaCorp® (BioScience GmbH,some level of response. Germany) showed no extra benefit. n This studyneocollagenesis noted in documents the efficacyother studies. There was little evidence of delayed of CaHA in the Conclusionsbiostimulatory effect of collagen formation owing to HA treatment of atrophic CaHA is biosynthetically produced and does not elicit ainjections, although the physical act of injection and acne scars. The author chronic inflammatory or immune response. In vivo andsubcision was of some benefit to the patient. is aware that these in vitro studies have established the biocompatibility and benefits may last 18 Side-effects of treatment were mostly limited in the months or more safety of CaHA. No evidence of granuloma formation,group to mild transient erythema, bruising or localised ossification, or foreign body reactions have been found inoedema. Some patients required top-up or remodelling long-term animal studies. CaHA implants have persistedon initial review. One 23-year-old male patient (skin type intact at the injection site in areas such as the face at up to References 1. Burton JL, Cunliffe WJ, Stafford I, Shuster photorejuvenation and inflammatory acne 16. Tzikas TL. Evaluation of the Radiance FN undergoing treatment with antiretroviral S. The prevalence of acne vulgaris in vulgaris. Br J Dermatol 2006; 155(4): 748–55 soft tissue filler for facial soft tissue drugs. Dermatol Surg 2006; 32(6): 804–8 adolescence. Br J Dermatol 1971; 85 (2): 119–26 9. Nouri K, Rivas MP, Bouzari N, Faghih S. augmentation Arch Facial Plast Surg 2004; 23. Product used to enlarge lips can cause 2. Cunliffe WJ. The acnes. London: Dunitz, Nonablative lasers. J Cosmet Dermatol 2006; 6(4): 234–9 bumps. Bioform does not recommend using 1989 5(2): 107–14 17. Marmur ES, Phelps R, Goldberg DJ. Clinical, this product on the red portion of lips. 3. Layton AM, Henderson CA, Cunliffe WJ. A 10. Bellew SG, Lee C, Weiss MA, Weiss RA. histologic and electron microscopic findings after injection of a calcium hydroxyapatite click2houston.com clinical evaluation of acne scarring and its Improvement of atrophic acne scars with a incidence. Clin Exp Dermatol 1994; 19(4): 1,320 nm Nd:YAG laser: retrospective study. filler. J Cosmet Laser Ther 2004; 6(4): 223–6 24. Goldberg DJ, Snehal A, Hussain M. Acne 303–8 Dermatol Surg 2005; 31(9 Pt 2): 1218–21 18. Godin MS, Majmundar MV, Chrzanowski scar correction using calcium hydroxylapatite 4. Wu SF, Kinder BN, Trunnell TN, Fulton JE. 11. Prieto VG, Zhang PS, Sadick NS. Evaluation DS, Dodson KM. Use of radiesse in in a carrier-based gel. J Cosmet Laser Ther Role of anxiety and anger in acne patients: a of pulsed light and radiofrequency combined combination with restylane for facial 2006; 8(3): 134–6 relationship with the severity of the disorder. for the treatment of acne vulgaris with augmentation Arch Facial Plast Surg 2006; 25. Alam M, Dover JS. Treatment of acne J Am Acad Dermatol 1988; 18(2 Pt 1): 325–33 histologic analysis of facial skin biopsies J 8(2): 92–7 scarring. Skin Therapy Lett 2006; 11(10): 7–9 5. Cotterill JA, Cunliffe WJ. Suicide in Cosmet Laser Ther 2005; 7(2): 63–8 19. Goldberg DJ. Fillers in Cosmetic Dermatology. Abingdon, Oxon, UK: Informa, 26. Buck DW 2nd, Alam M, Kim JY. Injectable dermatological patients. Br J Dermatol 1997; 12. Majid I. Microneedling therapy in atrophic 137(2): 246–50 facial scars: an objective assessment. J Cutan 2006 fillers for facial rejuvenation: a review. J Plast Aesthet Surg 2009; 2(1): 26–30 20. Roy D, Sadick N, Mangat D. Clinical trial of Reconstr Aesthet Surg 2009; 62(1): 11–8 6. Omi T, Kawana S, Sato S, Bonan P, Naito Z. Fractional CO2 laser for the treatment of acne 13. Coleman WP Lipocytic dermal a novel filler material for soft tissue 27. Orentreich DS, Orentreich N. scars. J Cosmet Dermatol 2011; 10(4): 294–300 augmentation. In: Klein AW. ed, Tissue augmentation of the face containing Subcutaneous incisionless (subcision) 7. Hedelund L, Haak CS, Togsverd-Bo K, Bogh augmentation in clinical practice. Procedures synthetic calcium hydroxylapatite surgery for the correction of depressed scars MK, Bjerring P, Hædersdal M. Fractional CO2 and techniques. New York: Marcel Dekker, microspheres. Dermatol Surg 2006; 32(9): and wrinkles. Dermatol Surg 1995; 21(6): laser resurfacing for atrophic acne scars: a 1998: 49–62 1134–9 543–9 randomized controlled trial with blinded 14. Coleman SR. Long-term survival of fat 21. Comite SL, Liu JF, Balasubramanian S, 28. Chandrashekar BS, Nandini A. Acne scar response evaluation. Lasers Surg Med 2012; transplants: controlled demonstrations. Christian MA. Treatment of HIV-associated 44(6): 447–52 Aesthetic Plast Surg 1995; 19(5): 421–5 facial lipoatrophy with Radiance FN subcision J Cutan Aesthet Surg 2010; 3(2): (Radiesse). Dermatol Online J 2004; 10(2): 2 125–6 8. Seaton ED, Mouser PE, Charakida A, Alam 15. Chu A, et al. A pilot study to assess the S, Seldon PM, Chu AC. Investigation of the efficacy of Isolagen (autologous fibroblasts) 22. Treacy PJ, Goldberg DJ. Use of a 29. Goodman GJ, Baron JA. Postacne scarring mechanism of action of nonablative treatment in acne scarring. Br J Dermatol biopolymer polyalkylimide filler for facial – a quantitative global scarring grading pulsed-dye laser therapy in 2006 lipodystrophy in HIV-positive patients system. J Cosmet Dermatol 2006; 5(1): 48–5248 ❚ March 2013 | prime-journal.com
  • 6. | dermatology | peer-review Figure 6 Improvement rates in patient cohort treatment with CaHA Figure 7 Improvement rates in patient cohort treatment with HA 27 13 12 24 11 21 10 9 Number of patients 18 Number of patients 8 15 7 12 6 5 9 4 6 3 2 3 1 0 0 4 weeks 12 week 24 weeks 48 weeks 4 weeks 12 weeks 24 weeks 48 weeks 0-25% 25-50% 50-75% 75-100% 0-25% 25-50% 50-75% 75-100%12–18 months. No skin testing is required for the  Declaration of interest Nonecompound as company information states that noanimal or animal products are used in the manufacture  Figures 2–7 ©Patrick Treacyof the product, thus there is no risk of transmitting diseaseor causing allergic reactions in patients who are sensitive  Patrick Treacy will present on the DUBLiN Lift at AMWCto common foods. 2013: 16.30, Friday 5 April, Room Van Dongen This study documents the efficacy of CaHA in thetreatment of atrophic acne scars. The author is aware thatthese benefits may last 18 months or more. 4154 1_2 page_Layout 1 21/12/2012 16:22 Page 1 Each cannula with screw thread polycarbonate hub, is supplied one size smaller Silkann flexible aesthetic cannulas packaged with Sterimedix sharp needles than the accompanying sharp pre-hole needle, More comfortable for your patients. giving practitioners the perfect match between More efficient for you. cannula and needle to ensure maximium accuracy whilst maintaining optimum patient comfort. Available in the UK through For more information call: +44 (0)1527 405860 or visit: www.silkann.com Tel: 0800 7830605 Silkann is a registered trade mark of Sterimedix Limited sales@medfx.co.uk