6. BRIEF RESUME OF INTENDED STUDY
6.1. NEED OF THE STUDY-
Acne vulgaris, mostly a disease of adolescence and mid-twenties, presents as a considerable challenge to the dermatologist. It is so because of the disfigurement it produces on the face, which is socially and psychologically the most significant body part. It occurs worldwide, affecting more than 90% of people. Teenagers who are the worst affected by acne not only suffer because of it, but also because of its dreaded sequelae, the scarring. The patients undergo various psychosocial disturbances like poor quality of life, depression & social dysfunction.
Till now microdermabrasion, lasers, punch technique & dermal grafting were the treatment options available for the patients1. However, with the advent of microneedling and platelet rich plasma (PRP) therapy for atrophic scars, new avenues for treatment of acne scars can be explored. Skin needling has been used since 1995 to achieve percutaneous collagen induction (PCI)2. It is an effective method for treating acne scars (grades 2–3) and other dermatological lesions. The technique involves puncturing the skin multiple times with a small needle to induce collagen growth. Microneedling, which is basically done using dermaroller, is safe, painless, cost-effective procedure with minimal side effect attached with it. Platelet Rich Plasma on the other hand provides with various growth factors which aid in quick wound healing. By combining these two modes of treatment we can expect better results in treatment of acne scars and relief for patients from various emotional stresses & psychosocial disturbances.
6.2. REVIEW OF LITERATURE -
Acne vulgaris is a disorder of the pilosebaceous unit that is seen primarily in adolescents, presenting as comedones, papules, pustules and nodules.3 Age of onset of acne being at puberty or few months earlier with peak of incidence between14-17 years in women and 16-19 years in men.4Although it is self-limiting, its sequelae may be lifelong with atrophic or hypertrophic scars. Scarring is one of the most complex biological processes which involve various chemical mediators, extracellular matrix, parenchymal resident cells and infiltrating blood cells. Atrophic scars can be of three types-icepick, rolling and boxcar. They are graded as macular (grade 1), mild (grade 2), moderate (grade 3) and severe (grade 4) in increasing order of severity (Table1). 5 Dre´no et al created a grading scale to quantify the severity of acne scars, known as the ECCA scale, which is designed for use in clinical practice with a goal of standardizing discussions about treatment of scar.6
Present surgical modalities to treat acne scars include subcision, punch excision, punch grafting and lasers.7 Recently, microneedling therapy has assumed a dominant role in acne scar treatment. It is based on the principle of percutaneous collagen induction therapy. Dermaroller is a mode of application of this principle which was first devised by Fernandes in 2006.8 In a study conducted by Imran Majid, 36 out of 37 patients showed good response to dermaroller treatment.9
At the same time PRP has been used for various surgical and medical fields. Face and neck rejuvenation is a field that is currently being explored. A three month study conducted by Alessio Radaelli, with 23 patients was found to be promising in face and neck rejuvenation and scar attenuation.10 In another study by Dae Hun Kim.et.al, autologous PRP was found to stimulate fibroblasts growth and thereby helping in scar healing.11
A study done by Gabriella Fabbrocini.et.al found that PRP combined with dermaroller was more effective in acne scars than dermaroller alone.12
Grades of Post acneScarring / Level of disease / Clinical features
1 / Macular / Erythematous, hyper- or hypopigmented flat marks. No problem of contour like other scar grades but of color.
2 / Mild / Mild atrophy or hypertrophy scars that may not be obvious at social distances of >/= 50 cm and may be covered adequately by makeup or the normal shadow of shaved beard hair in men or normal body hair if extrafacial.
3 / Moderate / Moderate atrophic or hypertrophic scarring that is obvious at social distances >/= 50cm and is not covered easily by makeup or the normal shadow of shaved beard hair in men or body hair if extrafacial, but is still able to be flattened by manual stretching of the skin (if atrophic).
4 / Severe / Severe atrophic or hypertrophic scarring that is evident at social distances >50 cm and is not covered easily by makeup or the normal shadow of shaved beard hair in men or body hair if extrafacial and is not able to be flattened by manual stretching of the skin.
6.3. AIMS AND OBJECTIVES-
To compare the efficacy of dermaroller alone against dermaroller with platelet rich plasma in a split face study on atrophic post acne scars patients attending Dermatology OPD in Victoria Hospital and Bowring & Lady Curzon Hospital.
7. METHODS AND MATERIALS-
7.1. SOURCE OF DATA:
Thirty patients of acne scars attending the Dermatology OPD in Victoria Hospital and Bowring & Lady Curzon Hospital attached to BMC & RI during the period from November 2012 to October 2014.
7.2. METHOD OF STUDY-
A study of 40 patients presenting with acne scars to the Dermatology OPD of Victoria Hospital and Bowring & Lady Curzon Hospital will be taken up for study. First the patients will be elaborately explained about the procedure and consent will be taken. Then the patient will be thoroughly evaluated & grading of the acne scars will be done using ECCA scale. The patient will be explained about the dermaroller and PRP therapy, the cost factor involved, benefits, duration of the treatment, possible side effects and the prognosis of the treatment. An informed consent will be taken. Digital photographs of both sides of face will be taken. Then topical anaesthesia will be applied. As a standard procedure, right side of the face will be subjected to dermaroller alone, while left side of the face will be treated with both dermaroller and PRP. The patient will be reviewed after one week for any side effects. A total of 4 similar sittings will be done at intervals of 4 weeks each. At the end of the treatment duration the scars will be graded using grading system as used in the beginning, photographs of both sides of the face will be taken and compared.
Sample size-40
The collected data will be analysed using Z-test or ANOVA test. The significance of the outcome of the study will be assessed by calculating the “P” value.
INCLUSION CRITERIA-
All male and female patients presenting with Grade 2 to Grade 4 acne scars.
EXCLUSION CRITERIA-
Any patients having-
1. Active nodulo-cystic acne.
2. Patients having keloid scarring or keloidal tendency
3. Diabetes
4. Bleeding disorder
5. Oral Steroid therapy
6. Anti-coagulant therapy
7. Active skin infection, like Herpes infection and bacterial infection.
8. Warts
9. Pregnancy
10. Patients having received Oral Isotretinoin for acne during last one month.
7.3. Does the study need any investigation and intervention to be conducted on patients or on other humans and animals? If yes, please describe briefly:
YES. Routine blood investigations will be done to rule out any systemic disorders. Dermaroller application will be done after topical anaesthetic application.
7.4. Has ethical committee clearance been taken from the institute for the above study?
Awaited.
8. LIST OF REFERENCES-
1.G.Fabbrocini, M.C. Annunziata, et al; Acne Scars- Pathogenesis, Classification and Treatment, Dermatology Research and Practice, Vol 2010,Article ID 893080,13 pages, doi 10.1155/2010/893080.
2. Orentreich DS, Orentreich N. Subcutaneous incisionless (subcision) surgery for the correction of depressed scars and wrinkles. Dermatol Surg 1995; 21: 543–9.
3.Andrea.L.Z,Emmy.M.G,Diane.M.T,John.S.S;Chapter-78,Acne Vulgaris and acneform eruptions,690-703,Fitzpatrick’s Dermatology in General Medicine,7th Edition,2008,Mc Graw Hill.
4.M.A.Tutakne,S.S.Viashampayan:Chapter-27, Acne, Rosacea and Perioral dermatitis,837-863,IADVL Textbook of Dermatology, Third Edition,2008 ,Bhalani Publishing House, Mumbai, India.
5. G.J.Goodman and J.A.Baron; Post Acne Scarring: A qualitative global scarring grading system. Dermatologic Surgery, Vol-32, no.12, pp.1458-1466, 2006
6. Diane Thiboutot et.al: New insights into the management of Acne: An update from the Global Alliance to improve outcomes in Acne group, Journal of the American Academy of Dermatology, 2009; 60:S1-50.
7. Albert. E. Riviera, DO; Acne Scarring: A review and current treatment modalities, Journal of the American Academy of Dermatology, 2008:59:659-76.
8. Desmond Fernandes: Minimally Invasive Percutaneous Collagen Induction, Oral and maxillofacial surgery clinics of North America 17(2005) 51-63.doi 10.1016/j.coms.2004.09.004.
9. Imran Majid :Microneedling therapy in atrophic facial scars: An objective assessment ,Journal of Cutaneous and Aesthetic Surgery, Jan-Jun 2009,Vol 2,Issue 1.
10. Alessio Radaelli: Face and Neck revitalization with Platelet rich plasma: clinical outcome in a series of 23 consecutively treated patients: Journal of Drugs in Dermatology. May 1, 2010,Vol 9. Issue 5
11. Dae Hun Kim et.al, Ann Dermatology, Vol 23, No.4, 2011 pg 424.
12. Gabriella Fabbrocini et.al; Skin Needling and Platelet Rich Plasma in Acne Scarring treatment: Cosmetic Dermatology, Vol-24, No.4, April 2011.