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Acne ScarPhase 2/3NCT05573425

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

A Phase 2/3 study testing Tazarotene gel 0.1% and Microneedling in people with Acne Scar, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Acne Scar
What is being tested?
Tazarotene gel 0.1% and Microneedling
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 sitePakistan
Study dates
22 Aug 2020to 21 Feb 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Jinnah Post graduate medical center

    Karachi, Sindh, 75510

Other trials in Pakistan

About this study

Official title: Comparing the Efficacy of Topical Tazarotene Gel 0.1% Versus Microneedling in Atrophic Post Acne Scars

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.

Read the detailed 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.

Conditions
Acne Scar
Being tested
Tazarotene gel 0.1%, Microneedling
Keywords
Tazarotene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tazarotene gel 0.1%Drug

    Also called Tazret gel 0.1%

    Tazarotene gel 0.1% applied daily on Acne Scars.

  • MicroneedlingDevice

    Also called Dermaroller device

    Microneedling via dermaroller device performed on Acne Scars monthly.

Study groups in NCT05573425
Study groupRoleWhat they receive
Group on Treatment:Tazarotene GelActive comparatorIn 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%
Receives: Drug: Tazarotene gel 0.1%
Group on Treatment:MicroneedlingActive comparatorIn 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
Receives: Device: Microneedling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in morphology of Acne Scars

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start22 Aug 2020
  3. Primary completion21 Feb 2021
  4. Study completion21 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05573425
Sponsor's protocol ID
Jpmc
Status last verified
Oct 2022
First submitted
5 Oct 2022
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tazarotene gel 0.1% and Microneedling in people with Acne Scar, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in morphology of Acne Scars (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.

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