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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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% Receives: 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 Receives: Device: Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted10 Oct 2022
- Study start22 Aug 2020
- Primary completion21 Feb 2021
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Faiza Shabbir, Jinnah Postgraduate Medical Centre
- Investigators
- Rabia Ghafoor, Study director, Jinnah Postgraduate Medical Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Topical Tazarotene Gel 0.1% Versus Microneedling in Atrophic Post Acne Scars
- ClinicalTrials.gov ID
- NCT05573425
- Acronym / sponsor ID
- Jpmc
- Conditions
- Acne Scar
- Keywords
- Tazarotene
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 22 Aug 2020 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group on Treatment:Tazarotene Gel | Active comparator | Drug: Tazarotene gel 0.1%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% |
| Group on Treatment:Microneedling | Active comparator | Device: MicroneedlingIn 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tazarotene gel 0.1%Also: Tazret gel 0.1%Tazarotene gel 0.1% applied daily on Acne Scars. | Drug | Group on Treatment:Tazarotene Gel |
| MicroneedlingAlso: Dermaroller deviceMicroneedling via dermaroller device performed on Acne Scars monthly. | Device | Group on Treatment:Microneedling |
Primary outcome
Change in morphology of Acne Scars
Time frame: 12 weeks
There is a change in Acne Scars assessed by Goodman and Baron Qualitative Acne Scars Grading system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Acne Scar
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
Recruiting
Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
Acne Scars
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
Poly-L-Lactic Acid in Atrophic Acne Scars
Atrophic Acne Scarring
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia Ghafoor study director
Jinnah Postgraduate Medical Centre
1 site in 1 country: see every site and its status.
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.