Atrophic Post Acne ScarringNCT03170596
Comparison Between Microneedling Daycare Procedure and Tazarotene 0.1% Gel Local Application in Acne Scarring
A study testing tazarotene gel 0.1% and Microneedling in people with Atrophic Post Acne Scarring, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Post Acne Scarring
- 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
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 2 Jun 2017to 29 Mar 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Known hypersensitivity to tazarotene
- Age less than 18 years
- Patients on anticoagulant therapy or aspirin
Trial locations and contacts
1 site in 1 country.
India1 site
Dermatology OPD, New OPD Building, Level 5C, Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
About this study
Official title: Microneedling Versus Topical Tazarotene 0.1% Gel for the Treatment of Atrophic Post Acne Scarring - a Randomized Controlled Study
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.
- Conditions
- Atrophic Post Acne Scarring
- Being tested
- tazarotene gel 0.1%, Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tazarotene gel 0.1%Drug
Patients will be instructed to apply 0.1% tazarotene gel as a thin film over the affected area once daily in the evening.
MicroneedlingDevice
Microneedling is a method of percutaneous collagen induction
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene gel arm | Experimental | The treatment protocol in this arm will consist of night time application of Tazarotene 0.1% gel during the entire study period. (3 months) Receives: Drug: tazarotene gel 0.1% |
| Microneedling arm | Active comparator | The treatment protocol in this arm will consist of four sessions of microneedling at monthly intervals. (0, 1, 2, 3 months) Receives: Device: Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne scar severity grade at final visit
Change in acne scar severity grade from baseline and at 6 months
Measured: 6 months
Secondary outcomes (3)
Acne scar severity grade at final visit at 3 months
Change in acne scar severity grade from baseline and at 3 months
Measured: 3 months
Patient satisfaction
Patient satisfaction using Patient's global assessment score done at 6 months
Measured: 6 months
Adverse events
Adverse events noted in both arms during the study period of 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start2 Jun 2017
- Primary completion28 Feb 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrophic Post Acne ScarringStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Microneedling procedure will be done on one half of the face and patients will be instructed to apply tazarotene 0.1% gel on the other half of the face
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tarun Narang, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Tarun Narang, MD, Study chair, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170596
- Sponsor's protocol ID
- NK/3486/MD
- Status last verified
- Apr 2018
- First submitted
- 26 May 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529.
PubMed 20808602Webster 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.
PubMed 12095066Phillips 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. doi: 10.1001/archderm.138.11.1486.
PubMed 12437455Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
PubMed 17199653Afra TP, Razmi T M, Narang T, Dogra S, Kumar A. Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial. JAMA Facial Plast Surg. 2019 Mar 1;21(2):125-132. doi: 10.1001/jamafacial.2018.1404.
PubMed 30452511
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling Versus Topical Tazarotene 0.1% Gel for the Treatment of Atrophic Post Acne Scarring - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03170596
- Acronym / sponsor ID
- NK/3486/MD
- Conditions
- Atrophic Post Acne Scarring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 31 May 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Microneedling procedure will be done on one half of the face and patients will be instructed to apply tazarotene 0.1% gel on the other half of the face
| Arm | Type | Receives |
|---|---|---|
| Tazarotene gel arm | Experimental | Drug: tazarotene gel 0.1%The treatment protocol in this arm will consist of night time application of Tazarotene 0.1% gel during the entire study period. (3 months) |
| Microneedling arm | Active comparator | Device: MicroneedlingThe treatment protocol in this arm will consist of four sessions of microneedling at monthly intervals. (0, 1, 2, 3 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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%Patients will be instructed to apply 0.1% tazarotene gel as a thin film over the affected area once daily in the evening. | Drug | Tazarotene gel arm |
| MicroneedlingMicroneedling is a method of percutaneous collagen induction | Device | Microneedling arm |
Primary outcome
Acne scar severity grade at final visit
Time frame: 6 months
Change in acne scar severity grade from baseline and at 6 months
3 secondary outcomes
Acne scar severity grade at final visit at 3 months
Time frame: 3 months
Patient satisfaction
Time frame: 6 months
Adverse events
Time frame: 6 months
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 4 Apr 2018.
- Background: PubMed 20808602Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529.
- Background: PubMed 12095066Webster 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.
- Background: PubMed 12437455Phillips 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. doi: 10.1001/archderm.138.11.1486.
- Background: PubMed 17199653Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
- Derived from this study: PubMed 30452511Afra TP, Razmi T M, Narang T, Dogra S, Kumar A. Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial. JAMA Facial Plast Surg. 2019 Mar 1;21(2):125-132. doi: 10.1001/jamafacial.2018.1404.
- Individual participant dataSharing planned: No
Related trials for Atrophic Post Acne Scarring
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
Not yet recruiting
Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
Acne Scars, Acne Scars - Atrophic
Not yet recruiting
Efficacy and Safety of Combined Nanofat Injection With Either Platelet Rich Fibrin or Microneedling Versus Nanofat Injection Alone in the Treatment of Facial Atrophic Post Acne Scars
Acne Scars - Atrophic
Recruiting
PRP Plus Fractional CO₂ Laser for Acne Scars
Post-Acne Atrophic Scars, Carbon Dioxide Lasers
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.
Tarun Narang, MD study chair
Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tazarotene gel 0.1% and Microneedling in people with Atrophic Post Acne Scarring, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 2 inclusion and 9 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 4 Apr 2018. 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 India. 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.
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?
Acne scar severity grade at final visit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170596, which also lists 5 linked publications.
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 4 Apr 2018.