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Completed

NCT Number: NCT03170596

Comparison Between Microneedling Daycare Procedure and Tazarotene 0.1% Gel Local Application in Acne Scarring

Post acne scarring is a common complication of acne. Cosmetic appearance of the post acne facial scarring can be improved by various methods. Among the procedural methods microneedling (1) is a novel and a promising option. It is a minimally invasive day care procedure for the management of atrophic acne scars. Topical tazarotene 0.1% gel is an effective medical method in the management of acne vulgaris and macular acne scars (2, 3). Based on its mechanism of action and role in collagen synthesis, topical tazarotene is a logical choice to investigate for the management of atrophic post acne scars. This is a pilot study comparing microneedling and topical tazarotene for the treatment of atrophic post acne scarring in regard to extent and rapidity of improvement, patient satisfaction and any adverse events if any.

Thirty six subjects with grade 2 to grade 4 atrophic post acne scars, classified on the basis of Goodman's Qualitative classification (4) criteria will be recruited. Goodman's qualitative and quantitative acne scarring grading system scoring will be performed for the assessment of severity of acne scarring at baseline. The face of each patient will be randomized for monthly microneedling on one side and topical tazarotene 0.1 % gel once a day local application on opposite side, using computer generated random number table. Follow ups will be done at every month until treatment completion (3 months) and 3 months after the last treatment session. Goodman's qualitative and quantitative acne scarring grading system scoring will be performed at 3rd and 6th month follow up visits. An improvement by two grades will be considered as excellent, one grade will be rated as good and no up gradation will be labelled as poor response. Patients will be also assessed by a blinded observer for clinical improvement and scored on a scale of 0 (no improvement) to 10 (maximum) at 3rd and 6th month follow up visits with the help of serial photographs taken under consistent background, position and lighting. All patients will be instructed to assess themselves using Patients' Global Assessment Score 0 (no response) to 10 (maximum) at 3rd and 6th month follow up visits.

The investigators hope the outcome of the present study may propose a newer medical modality for acne scarring, i.e topical tazarotene 0.1% gel, which can be used at home, obviating the need for physician dependant microneedling procedure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology OPD, New OPD Building, Level 5C, Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with grade 2 to grade 4 atrophic acne scars, classified on the basis of Goodman's Qualitative classification.6
  • Should not have undergone any surgical and/or laser treatment for acne scars in the past 1 year.

Exclusion criteria

  • Active acne
  • History of keloidal tendency/hypertrophic or keloidal scarring on the face due to acne
  • Facial scars due to reasons other than acne like varicella, trauma, burns etc
  • Collagen vascular disease, bleeding disorders
  • Any active bacterial , fungal or viral infection over face
  • Pregnant and lactating females
  • Known hypersensitivity to tazarotene
  • Age less than 18 years
  • Patients on anticoagulant therapy or aspirin

Treatment and study plan

tazarotene gel 0.1%

Drug

Patients will be instructed to apply 0.1% tazarotene gel as a thin film over the affected area once daily in the evening.

microneedling

Device

Microneedling is a method of percutaneous collagen induction

Primary outcomes

  1. Acne scar severity grade at final visit

    Time frame: 6 months

    Change in acne scar severity grade from baseline and at 6 months

Secondary outcomes

  1. Acne scar severity grade at final visit at 3 months

    Time frame: 3 months

    Change in acne scar severity grade from baseline and at 3 months

  2. Patient satisfaction

    Time frame: 6 months

    Patient satisfaction using Patient's global assessment score done at 6 months

  3. Adverse events

    Time frame: 6 months

    Adverse events noted in both arms during the study period of 6 months

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Microneedling Versus Topical Tazarotene 0.1% Gel for the Treatment of Atrophic Post Acne Scarring - a Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 31, 2017
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.