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

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ClinicalTrials.gov Identifier: NCT03170596
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Tarun Narang, Postgraduate Institute of Medical Education and Research

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrophic Post Acne Scarring Drug: tazarotene gel 0.1% Device: Microneedling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Microneedling procedure will be done on one half of the face and patients will be instructed to apply tazarotene 0.1% gel on the other half of the face
Masking: Single (Outcomes Assessor)
Masking Description: An independant senior dermatologist who is blinded regarding the modality used for atrophic acne scarring in each half of the face, will be assessing the outcome scores.
Primary Purpose: Treatment
Official Title: Microneedling Versus Topical Tazarotene 0.1% Gel for the Treatment of Atrophic Post Acne Scarring - a Randomized Controlled Study
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : March 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: Tazarotene gel arm
The treatment protocol in this arm will consist of night time application of Tazarotene 0.1% gel during the entire study period. (3 months)
Drug: tazarotene gel 0.1%
Patients will be instructed to apply 0.1% tazarotene gel as a thin film over the affected area once daily in the evening.

Active Comparator: Microneedling arm
The treatment protocol in this arm will consist of four sessions of microneedling at monthly intervals. (0, 1, 2, 3 months)
Device: Microneedling
Microneedling is a method of percutaneous collagen induction




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170596


Locations
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India
Dermatology OPD, New OPD Building, Level 5C, Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Study Chair: Tarun Narang, MD Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Tarun Narang, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03170596     History of Changes
Other Study ID Numbers: NK/3486/MD
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrophy
Cicatrix
Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes
Nicotinic Acids
Tazarotene
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs