Comparing the Efficacy of Topical Tazarotene Gel 0.1% v/s Microneedling in Atrophic Post Acne Scars

NCT05573425 | Completed Phase 2

• 1 other identifier: Jpmc
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Scar

Keywords

Tazarotene

Outcome Measures

Primary Outcomes (1)

• Change in morphology of Acne Scars

  There is a change in Acne Scars assessed by Goodman and Baron Qualitative Acne Scars Grading system

  12 weeks

Study Arms (2)

Group on Treatment:Tazarotene Gel

ACTIVE COMPARATOR

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. Intervention - Tazarotene gel 0.1%

Drug: Tazarotene gel 0.1%

Group on Treatment:Microneedling

ACTIVE COMPARATOR

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. Intervention - Microneedling via dermarolller

Device: Microneedling

Interventions

Tazarotene gel 0.1% DRUG

Tazarotene gel 0.1% applied daily on Acne Scars.

Also known as: Tazret gel 0.1%

Group on Treatment:Tazarotene Gel

Microneedling DEVICE

Microneedling via dermaroller device performed on Acne Scars monthly.

Also known as: Dermaroller device

Group on Treatment:Microneedling

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders.
• Age from 18 to 40 years.
• Atrophic post-acne scar patients with duration 4 to 8 years.
• Informed consent will be obtained.
• Patients with grade 2 to 4 facial atrophic post-acne scars as assessed by the Goodman and Baron qualitative global scarring grading system.

You may not qualify if:

• Pregnant or lactating woman.
• Patients having any allergy related to given drug.
• History of keloidal tendency or hypertrophic scarring.
• Those with active acne or acne marks such as red, black or brown macular marks.
• Patients with a previous history of dermabrasion or laser resurfacing on the face.
• Facial scar due to reasons other than acne, collagen vascular disease or bleeding disorder.
• Patients with a treatment history of \<4 weeks for topical retinoid and alpha/beta hydroxy acids, \<3 months for microdermabrasion and \<6 months for oral retinoids.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah Post graduate medical center

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Rabia Ghafoor

  Jinnah Postgraduate Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: August 22, 2020
• Primary Completion: February 21, 2021
• Study Completion: February 21, 2021
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)