Atrophic Post Acne Scarring Clinical Trial
Official title:
Microneedling Versus Topical Tazarotene 0.1% Gel for the Treatment of Atrophic Post Acne Scarring - a Randomized Controlled Study
| Verified date | April 2018 |
| Source | Postgraduate Institute of Medical Education and Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | March 29, 2018 |
| Est. primary completion date | February 28, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Dermatology OPD, New OPD Building, Level 5C, Postgraduate Institute of Medical Education and Research | Chandigarh |
| Lead Sponsor | Collaborator |
|---|---|
| Postgraduate Institute of Medical Education and Research |
India,
Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529. — View Citation
Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. — View Citation
Phillips TJ, Gottlieb AB, Leyden JJ, Lowe NJ, Lew-Kaya DA, Sefton J, Walker PS, Gibson JR; Tazarotene Cream Photodamage Clinical Study Group. Efficacy of 0.1% tazarotene cream for the treatment of photodamage: a 12-month multicenter, randomized trial. Arch Dermatol. 2002 Nov;138(11):1486-93. — View Citation
Webster GF, Guenther L, Poulin YP, Solomon BA, Loven K, Lee J. A multicenter, double-blind, randomized comparison study of the efficacy and tolerability of once-daily tazarotene 0.1% gel and adapalene 0.1% gel for the treatment of facial acne vulgaris. Cutis. 2002 Feb;69(2 Suppl):4-11. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Acne scar severity grade at final visit | Change in acne scar severity grade from baseline and at 6 months | 6 months | |
| Secondary | Acne scar severity grade at final visit at 3 months | Change in acne scar severity grade from baseline and at 3 months | 3 months | |
| Secondary | Patient satisfaction | Patient satisfaction using Patient's global assessment score done at 6 months | 6 months | |
| Secondary | Adverse events | Adverse events noted in both arms during the study period of 6 months | 6 months |