Comparing the Efficacy of Topical Tazarotene Gel 0.1% v/s Microneedling in Atrophic Post Acne Scars
Condition: Acne Scar
MeSH terms: Acne Vulgaris; Atrophy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to compare the Efficacy of Topical Tazarotene gel 0.1% versus
      Microneedling in atrophic Post acne scars. All patients of age 18-40 years, with grade 2 to
      grade 4 facial atrophic acne scars, assessed using the Goodman and Baron qualitative global
      scarring grading. Group A was given daily home application of Topical Tazarotene gel 0.1%
      while on Group B, Microneedling monthly sessions done for 12 weeks. The results were assessed
      by photographs, Goodman and Baron Qualitative Acne Scars Grading system at the start and end
      of treatment. SPSS 21 was used for data analysis which showed comparable efficacy of daily
      home based application of Topical Tazarotene gel 0.1% versus Microneedling monthly sessions
      in Atrophic Post Acne Scars.
    

Detailed description: 
      This was a randomized Control Trial, done in Department of Dermatology, Jinnah Postgraduate
      Medical Centre (JPMC), Karachi from August 22, 2020 to February 21, 2021.

      A total of 202 patients with 101 in each group. The sample size was estimated using WHO
      sample size calculator using statistics for efficacy in topical Tazarotene gel (group A) as
      30.5% and micro-needling (group B) as 47.2%,80% power of test and 95% confidence level. Both
      genders, 18 to 40 years with atrophic post-acne scar patients of duration 4 to 8 years were
      included. Informed consent was obtained. Patients with grade 2 to 4 facial atrophic post-acne
      scars assessed by Goodman and Baron qualitative global scarring grading system. While
      excluded pregnant/lactating woman, any prior allergy to given drug, history of keloidal
      tendency/hypertrophic scarring, active acne or acne marks such as red, black or brown macular
      marks, previous dermabrasion, laser resurfacing on face, facial scar due to reasons other
      than acne, collagen vascular disease, bleeding disorders, treatment history of <4 weeks for
      topical retinoid, alpha/beta hydroxyl acids, <3 months for microdermabrasion and <6 months
      for oral retinoids.

      This study was conducted after approval from ethical review committee and CPSP. During the
      patient first visit, baseline photographs were captured with informed consent. Dermoscopic
      examinations of predominant scar type (such as icepick, rolling or boxcar) and the ssca
      severity assessed according to the Goodman and Baron qualitative acne scarring grading
      systems for every patient. All patients were randomly divided into two groups using
      computer-generated sequential number placed in sealed envelopes and opened only before the
      commencement of the study. In group A, patients were instructed to apply a thin film of
      tazarotene gel 0.1% over the affected area once daily in the evening by placing a pea-sized
      amount of gel in the palm of the hand and using tip of a finger to cover the entire half of
      the face. Patients who experienced facial dryness were allowed to use a moisturizing cream
      during the day on entire face but use of any other medication on the face was prohibited. In
      group B, microneedling was performed with a standard dermaroller (192 needles of length 1.5
      mm) by the same investigator, once per month for 6 months. A topical anesthetic mixture of
      lignocaine and prilocaine was applied over the face in a thick layer under occlusion 1 hour
      before the procedure.

      Microneedling was performed by rolling the dermaroller with uniform and firm pressure in 4
      different directions (i.e, perpendicular and diagonal to each other) with to-and-fro motion
      up to 8 times (a total of 32 passes) or until the end point of uniform pinpoint bleeding was
      achieved. After treatment, the area was wetted with saline pads. The participants were
      instructed to follow strict photoprotective measures including the application of a
      broad-spectrum sunscreen with sun protection factor 30 over the entire face. All patients
      were followed up at 3 month and on 6 month from the baseline visit. Digital photographs were
      captured at 3 and 6 month follow-up visits. An improvement by 2 qualitative grades was
      considered excellent, by 1 grade was rated good, and by 0 grade was labeled a poor response.
      The outcome was the change from baseline in acne scar severity grade at 3 and 6 month
      follow-up visits. All the data was entered in a predesigned proforma. Biasness and confounder
      were controlled by strictly following the inclusion criteria.

      SPSS version 21 was used for data compilation and analysis. Frequencies and percentages were
      computed for qualitative variables like gender, scar type, treatment, scar severity grade at
      baseline, after 3 and 6 months and efficacy. Quantitative variables were presented as mean ±
      SD like age and duration of acne. Comparison between both groups for efficacy was done by
      using Chi square test. Effect modifier like age, gender and duration of disease were
      controlled through stratification. Post stratification, Chi square test was applied for
      categorical variables. Consider P <0.05 as significant.
    

Intervention name(s): Tazarotene gel 0.1%; Microneedling
Intervention type(s): Drug; Device
Intervention description(s): Tazarotene gel 0.1% applied daily on Acne Scars.; Microneedling via dermaroller device performed on Acne Scars monthly.
Other intervention name(s): Tazret gel 0.1%; Dermaroller device
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tazarotene