Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05573425 |
| Other study ID # |
Jpmc |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2020 |
| Est. completion date |
February 21, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
Jinnah Postgraduate Medical Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
