Krishna Deb Barman kdebbarman@yahoo.com A COMPARATIVE EVALUATION OF MICRONEEDLING ALONE VERSUS COMBINED SUBCISION AND MICRONEEDLING IN POST ACNE SCARS Krishna Deb Barman kdebbarman@yahoo.com

Maulana Azad Medical College, New Delhi, India

Acne is a common disease with considerable prevalence worldwide INTRODUCTION Acne is a common disease with considerable prevalence worldwide Post acne facial scarring is Devastating Psychologically distressing

Focal treatment with TCA Available Treatments Needling Laser resurfacing Chemical peels Microdermabrasion Dermal grafting Dermal fillers Platelet rich plasma Subcision Punch excision Punch elevation Fat transfer Implantation of autologous collagen ; cultured and expanded autologous fibroblasts Focal treatment with TCA

Subcision Safe, easy, well-tolerated and effective technique Introduction of a hypodermic needle just under the dermis to release fibrous attachments leading to - skin elevation controlled trauma Initiates wound healing with formation of connective tissue Augments the depressed site

Skin Microneedling Creates thousands of microclefts in epidermis & papillary dermis leading to : Zone of superficial bleeding Initiates wound healing release of growth factors promote collagen deposition migration & proliferation of fibroblasts

Microneedling has been combined, wit variable success with other modalities like : Subcision Chemical peels 100% TCA CROSS

Microneedling targets superficial box scars Subcision targets primarily rolling scars Combination of the two would give better results.

AIMS AND OBJECTIVES To compare the efficacy of microneedling alone vs microneedling with subcision in the management of post acne scarring.

MATERIALS AND METHODS A total of 40 patients with acne scars were included and alternately labeled either as Group-A or -B. INCLUSION CRITERIA Patients with facial acne scars >18 years old  EXCLUSION CRITERIA Any skin resurfacing procedures within the preceding 1 year Systemic retinoids or immunosuppressive drugs during or within 6 months History of coagulation defects ,bleeding diathesis or keloids Active acne lesions

Detailed clinical history were taken Thorough general physical and dermatological examination Details were recorded in preset proforma Number, distribution and type of scarring noted Scored based on ECCA (Ecchelle D’ Evaluation Cliniques Des Cicatrices D’Acne)

Scars were counted, recorded and classified into icepick, box and round types To evaluate the improvement VAS (Visual analogue scale) by both physician and patient Complete blood investigations Written and informed consent were taken. Pre and post-treatment photographs were taken Procedures -performed using the same conditions in every sitting

Pre-procedure work up of acne scars

Post -Procedure Broad spectrum sunscreen ; strict avoidance of sun exposure to prevent pigmentation Details recorded using ECCA and self-devised quantitative grading for individual scars at baseline and in every subsequent visit Patient’s improvement was recorded on VAS at each visit Pre-Procedure photographs were taken at each visit

Instruments Used Dermaroller NoKoR Admix Needle Drum-shaped roller 20 mm wide studded with 192 fine microneedles in 8 rows of 24 each with a diameter of 0.25 mm & needle length of 2.0 mm. NoKoR Admix Needle A 18-gauge 1.5 inch NoKoR Admix needle non-coring vented needle with thin wall(Becton, Dickinson and Company, Franklin Lakes, NJ, USA)

Microneedling Topical anesthesia (EMLA cream - lidocaine 2.5% and prilocaine 2.5%) Patients were placed in a recumbent position ; area - cleaned, draped in a sterile manner. The dermaroller was rolled over both sides of the face with some pressure 4 times in 4 directions: horizontally, vertically, diagonally right and left. Appearance of uniform pinpoint bleeding : end point. Serum and blood -cleaned with saline soaked gauze Cold saline soaked gauze -applied for 5-10 minutes.

Combined Microneedling and Subcision After subcutaneous anesthesia Needle was inserted adjacent to a scar, parallel to the skin surface, just below the dermal-subcutaneous junction. Needle was advanced until resistance was felt ; then gently swept across Initial backward and forward motion -used to tunnel beneath the scar. After resistance started to decline, the needle was passed sideways in sweeping motion to complete the freeing up of the skin from the base.

This action - repeated in a fan-like pattern to treat the entire scar. Direct pressure was applied to prevent excessive bleeding. Once all the scars were treated with subcision procedure Skin microneedling was performed on both sides of face.

Post Procedure Photo protection ;broad spectrum sunscreens Reassurance - temporary erythema and edema Antibiotics and analgesics in group B. Subsequent sittings at monthly intervals till a total of 4 sittings. Patients were asked to follow up for another 2 months at monthly interval.

STATISTICAL ANALYSIS Statistical Package for Social Sciences (SPSS Inc.20.) Variables were analyzed was appropriate statistical tests P value of ≤ 0.05 was considered as significant. Continuous data were given as mean±SD, range or as median with interquartile range as appropriate. Normality of quantitative data : Kolmogorov Smirnov tests of normality Comparison of outcomes pre and post intervention: Paired-t test Analysis of Covariance : testing difference among the groups. Wilcoxon signed rank test : compare non parametric data Mann Whitney U test : compare the same among the two groups.

RESULTS

Epidemiological Profile Out of 40 only 37 patients completed the study Age ranged from 18-44 years Mean 25.80 years ; SD - 6.358 Majority (60%) : age group of 20-30 years. Sex ratio – equal Group-A had 11 males (55%) Group-B which had 9 males (45%) Majority were unmarried (80%) All of the patients were educated- 22 patients(55%) were graduate Thirty six patients (90%)employed

Clinical Profile Age of onset of scarring Age of onset of disease: 26 (65%) - ages of 14-20 years 7 (17.5%) - 14 years of age Rest 7(17.5%) had after 20 years Group-A 1 (5%) with onset before 14 yrs 15 (75%) between 14-20 yrs 4 (20%) onset after 20 yrs of age Group-B 6 (30%) had onset before 14 years 11 (55%) between 14-20 yrs 3 (15%) onset after 20 years of age Age of onset of scarring

Clinical Profile Duration varied from 1 to 25 years. Marjority (50%) had duration <5 yrs 25% with duration of 5-10 yrs 20% are with 11-15 years 5% had more than 15 years

Post surgery results in group A 19 patients completed the 4 sittings and followed up for the next 2 months Mean number of : Rolling : 13.65, SD- 14.67 Icepick : 47.45, SD- 23.536 Box : 30.20,SD -14.15

Statistical variable Rolling Icepick Box Total scars 20 13.65 47.45 Number of patients 20 Mean 13.65 47.45 30.20 91.30 Std. Error of Mean 3.282 5.263 3.164 8.562 Median 11.00 43.50 27.00 82.00 Mode 21 33 70 Std. Deviation 14.676 23.536 14.152 38.289 Range 53 99 63 172 Minimum 15 6 32 Maximum 114 69 204

Post surgery results group A Over the treatment periods the mean decreased as follows: Rolling scars 13.65 to 12.47 Icepick scars 47.45 to 45.11 Box scars 30.20 to 29.32 Total scars 91.30 to 82.55

Improvement in Group-A (Paired-Sample’s t-test) The reduction in mean count of – Rolling scars was found to be statistically significant from 4thvisit (p - 0.024 & 0.031 between baseline & 4th & 6th visit respectively ) Icepick scars was found to be statistically significant from 4th visit (p -0.013 & 0.019 between baseline & 4th & 6th visit) Boxcar scars was found to be statistically significant from 4th visit (p - 0.030 & 0.011 between baseline & 4th & 6th visit) Total number of acne scars was found to be statistically significant from 4th visit onwards (p value of 0.002 and 0.004)

ECCA SCORE (sample statistics) Parameters 95% Confidence Interval of the Difference   No.of patients Mean Std. Deviation Std. Error Mean Lower Upper Baseline 20 142.50 32.261 7.214 143.31 170.19 2nd visit 141.34 167.16 4th visit 138.00 33.182 7.420 140.84 166.16 6th visit 19 135.79 32.543 7.466 120.10 151.47

ECCA SCORE (sample statistics) The mean ECCA score in Group-A decreased from 142.50 to 135.79

ECCA scoring (Paired-Sample’s t-test) Comparison between Paired Differences t df Sig. (2-tailed) Mean Std. Deviation Std. Error Mean 95% Confidence Interval of the Difference Lower Upper Baseline-4th visit 4.500 11.799 2.638 -1.022 10.022 1.706 19 .104 Baseline-6th visit 4.737 12.073 2.770 -1.082 10.556 1.710 18

The reduction in mean ECCA scoring could not be calculated for Baseline and 2nd visit as the standard error of difference was 0. No statistically difference was found in ECCA scoring between baseline and 4th visit (p - 0.104) and 6th visit (p - 0.156)

VISUAL ANALOGUE SCALE The improvement in appearance of the patient with acne scars was evaluated by both the patient and the physician on a 4 point visual analogue scale as follows : 1 point for <25% improvement 2 points for 26-50% improvement 3 points for 51-75% improvement 4 points for >75% improvement

Visual Analogue Scale - A Patients At the end of the treatment 5% : marked improvement (50-75%) 74% : moderate improvement (25-50%) 21% : minimal improvement Difference in visual analogue scores was statistically significant from 3rd month onwards (p -0.014) Highly significant in 4th & 5th month (p=.001) Physician At the end of the treatment 84% : moderate improvement (25-50%) 16% : minimal improvement (<25%) Difference in visual analogue scores was statistically significant from 3rd month onwards (p = .005) Highly significant in 4th and 5th month (p < .001)

Pre-treatment Post-treatment

Combined Subcision And Microneedling Group Post surgery results in Group -B   Rolling Icepick Box Total scars Number of patients 20 Mean 21.95 79.65 51.90 153.50 Std. Error of Mean 3.623 8.473 5.149 13.163 Median 18.50 76.00 46.00 124.00 Mode 18 24 124 Std. Deviation 16.204 37.894 23.026 58.868 Range 56 130 72 154 Minimum 85 Maximum 148 96 239

Post surgery results in Group -B 18 patients Completed the 4 sittings Followed up for 2 months 2 patients Lost to follow up after 4 sittings Mean number Rolling scars 21.95, SD 16.204 Icepick scars 79.65, SD 37.894 Box scars 51.90, SD 23.02

Post surgery results : Group B Over the treatment period the mean decreased as follows : Rolling scars : 21.95 to 15.83 Icepick scars : 79.65 to 65.11 Box scars : 51.90 to 42.39 Total scars : 153.50 to 111

95% Confidence Interval of the Difference ECCA Score -B Parameters 95% Confidence Interval of the Difference   No. of patients Mean Std. Deviation Std. Error Mean Lower Upper Baseline 20 156.75 28.713 6.420 143.31 170.19 2nd visit 154.25 27.591 6.169 141.34 167.16 4th visit 153.50 27.053 6.049 140.84 166.16 6th visit 18 150.83 27.667 6.521 137.08 164.59

The mean ECCA score decreased from 156. 75 to 150 The mean ECCA score decreased from 156.75 to 150.83 over the treatment period

Improvement in ECCA scoring in Group-B (Paired-Sample t-test)   Paired Differences t df Sig. (2-tailed) Mean Std. Deviation Std. Error Mean 95% Confidence Interval of the Difference Lower Upper Baseline-2nd visit 2.5 7.695 1.721 -1.101 6.101 1.453 19 .163 Baseline-4th visit 3.25 8.156 1.824 -.567 7.067 1.782 .091 Baseline-6th visit 6.111 10.36 2.444 .955 11.267 2.500 17 .061 The reduction in mean ECCA scoring was not statistically different when compared to baseline values (p > .05)

Visual Analogue Scale-B Patients At the end of the treatment 50% : marked improvement (50-75%) 44% : moderate improvement (25-50%) 6% : minimal improvement (< 25%) Difference in visual analogue scores was statistically significant from 3rd month onwards (p = .002) and Highly significant in 4th and 5th month (p <.001) Physician At the end of the treatment 50% : marked improvement (50-75%) 50% : moderate improvement (25-50%) Difference in visual analogue scoring of patients by physician achieved a statistical significance from 2rd month onwards (p = .014) Highly significant in 3rd, 4th 5th month (p < .001)

Pre treatment Post treatment

COMPARING THE TWO GROUPS Group A : Microneedling alone vs Group B : Microneedling with Subcision

Rolling scars Mean number in Gr-A decreased by 8.6% over 6 months period as compared to 27.9% in Gr-B. On ANCOVA test, statistically significant difference was achieved starting from 2nd visit onward (p- 0.016) Highly significant in 4th & 6th visit (p- 0.001). The mean difference with baseline as covariate in ANCOVA test, between the two groups : positive on 2nd , 4th and 6th visit. Gr-B having more reduction in number of scars as compared to Group-A.

Icepick Scars Mean number of icepick scars in Gr-A decreased by 4.9% over 6 months as compared to 18.25% in Group-B. On ANCOVA test, statistical significant difference was not achieved at anytime from baseline.

Box Scars Mean number of box scars in Gr-A decreased by 2.91% over 6 months as compared to 18.32% in Group-B. On ANCOVA test, statistical significant difference achieved between baseline & 6th visit (p-0 .048). The mean difference was 4.868, implying that Group-B had more reduction as compared to Gr-A.

Total scars The mean number of total acne scars in Group-A decreased by 4.83% over 6 months as compared to 19.65% in Group-B. On ANCOVA test, no statistical significant difference was achieved.

ECCA SCORE The mean number ECCA score in Group-A decreased by 4.7% over 6 months as compared to 3.7% in Group-B. On ANCOVA test, no statistical significant difference was achieved anytime during the study period

VISUAL ANALOGUE SCALE BY PATIENTS There was statistical difference in VAS by the patients in the two groups from 2nd visit onwards (p <.05). The mean percentage improvement was 61% in Group-B as compared to 46% in Group-A at 5th month

VISUAL ANALOGUE SCALE BY PHYSICIAN The physician difference in visual analogue scoring was statistically different, beginning with 3rd visit (p < 0.05). The mean percentage improvement was 62.5% in Group-B as compared to 46% in Group-A at 5th month

Side effects Post Inflammatory Hyperpigmentation: 4 pts in Gr- A and 3 pts in Gr B developed post inflammatory hyperpigmentation : faded by the end of follow up period 1 patient had post inflammatory hyperpigmentation (also fading over time). No other significant adverse effects were noted

CONCLUSIONS AND RECOMMENDATIONS After evaluating and analyzing the results, we conclude that Microneedling is a effective treatment option in management of post acne scars Combining it with a single session of subcision can give better outcomes especially in - rolling and box type of scars. More studies, using larger sample size and more equitable distribution of patients are required to validate the results.