Acne ScarringNCT02174393
Microneedling Plus the Universal Peel For Acne Scarring
A study testing Universal Peel, Microneedling and Post-Microneedling Skin Care in people with Acne Scarring, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults. Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions, and depending on the skin type, significant erythema (redness) or post-inflammatory hyperpigmentation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acne Scarring
- What is being tested?
- Universal Peel, Microneedling and Post-Microneedling Skin Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2015
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject > 18 and < 60 years of age.
- Subject has skin type III, IV, V, or VI as defined by the Fitzpatrick Classification Scale.
- Subject has acne scarring as defined by the Goodman and Baron Grading System.
Who cannot join
- Subject currently has moderate to severe acne on the face.
- Subject has an active infection.
- Subject is pregnant or lactating.
- Subject has a history of a bleeding disorder.
- Subject is taking an anti-coagulant.
- Subject has a history of keloidal tendency.
- Subject has received ablative or non-ablative laser treatments in the previous 6 months.
- Subject has taken Accutane within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bergen Dermatology
Englewood Cliffs, New Jersey, 07632
About this study
Official title: Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI
Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults. Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions, and depending on the skin type, significant erythema (redness) or post-inflammatory hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the aforementioned types of lesions. Pharmacologic management is essential, but safe procedural therapies are also necessary specifically with darker skinned individuals.
Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using a micro-needling device, which is safe and effective in causing "micro-wounds" into the dermis thereby initiating wound healing followed by collagen production. This is an ideal treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin types . Currently there are very few studies evaluating the safety and efficacy of microneedling and chemical peels in skin types III-VI.
The aim of this study is to evaluate the effects of the combination of microneedling and chemical peel for the treatment of acne scars in skin types III-VI.
- Conditions
- Acne Scarring
- Being tested
- Universal Peel, Microneedling, Post-Microneedling Skin Care, Post-Universal Peel Skin Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal PeelDrug
Universal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol)
MicroneedlingProcedure or surgery
Microneedling: is a device for all skin types that creates micro "injuries" in the dermis (layer of the skin underneath the outermost layer) in an attempt to trigger new collagen (natural component of skin tissue) production for smoother, firmer and younger-looking skin.
For this protocol, the needle depth will be increased over the 3 sessions:
Forehead: 0.75 mm, 0.85 mm, 1.0 mm. Cheeks/Chin: 1.0 mm, 1.5 mm, 2.0 mm.
Each Session: Microneedling procedure on Day 1, followed by skin care regimen
Post-Microneedling Skin CareDrug
On Day 1 (after Microneedling procedure):
- Gentle Antioxidant Soothing Cleanser daily
- Soothing Recovery Ointment and Sheer Physical Sunscreen
On Day 2-7:
- AM: Physical sheer sunscreen and recovery ointment
- PM: Retinol/Vitamin C in the evening and soothing recovery ointment
On Day 7:
- AM: BD Hydrating Day/Night Cream
- PM: Retinol and Vitamin C and the BD Hydrating Day/Night Cream (if necessary)
Post-Universal Peel Skin CareDrug
- Gentle Antioxidant Soothing Cleanser daily
- Physical Sunscreen daily
- Soothing recovery ointment fortified with silver only when peeling occurs
- After completely peeling, vitamin c product in the morning and the retinol in the evening
| Study group | Role | What they receive |
|---|---|---|
| Microneedling Plus Universal Peel | Experimental | (1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each.
Microneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11. Receives: Drug: Universal Peel; Procedure: Microneedling; Drug: Post-Microneedling Skin Care; Drug: Post-Universal Peel Skin Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.
The scale will be completed at every office visit over the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Measured: 6 months
Improvement in the appearance of acne scarring as measured by the 4 Point Scar Scale.
The scale will be completed at each office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Measured: 6 Months
Improvement in the appearance of acne scarring as measured by the Global Assessment.
The Global Assessment of Improvement will be completed at Week 17.
Measured: 6 months
Secondary outcomes (3)
Improvement in the appearance of acne scarring as subjectively measured through digital pictures.
Pictures of the subject will be taken by the Principal Investigator at every office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Measured: 6 months
Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.
The Cardiff Index will be completed at Baseline and Week 17.
Measured: 6 months
Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.
Subject will complete a pre-treatment questionnaire at Baseline and post-treatment questionnaires at Weeks 7 and 17.
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 posted25 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Topix Pharmaceuticals, Eclipse Aesthetics
- Responsible party
- Sponsor
- Investigators
- Naana Boakye, MD, Principal investigator, Englewood Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174393
- Sponsor's protocol ID
- E-14-555
- Status last verified
- Feb 2016
- First submitted
- 20 Jun 2014
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI
- ClinicalTrials.gov ID
- NCT02174393
- Acronym / sponsor ID
- E-14-555
- Conditions
- Acne Scarring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Collaborators
- Topix Pharmaceuticals, Eclipse Aesthetics
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jun 2014 (estimated)
- 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.
Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults. Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions, and depending on the skin type, significant erythema (redness) or post-inflammatory hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the aforementioned types of lesions. Pharmacologic management is essential, but safe procedural therapies are also necessary specifically with darker skinned individuals.
Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using a micro-needling device, which is safe and effective in causing "micro-wounds" into the dermis thereby initiating wound healing followed by collagen production. This is an ideal treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin types . Currently there are very few studies evaluating the safety and efficacy of microneedling and chemical peels in skin types III-VI.
The aim of this study is to evaluate the effects of the combination of microneedling and chemical peel for the treatment of acne scars in skin types III-VI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microneedling Plus Universal Peel | Experimental | Drug: Universal Peel, Procedure: Microneedling, Drug: Post-Microneedling Skin Care, Drug: Post-Universal Peel Skin Care(1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each. Microneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject > 18 and < 60 years of age.
- Subject has skin type III, IV, V, or VI as defined by the Fitzpatrick Classification Scale.
- Subject has acne scarring as defined by the Goodman and Baron Grading System.
Key exclusion criteria (8 listed)
- Subject currently has moderate to severe acne on the face.
- Subject has an active infection.
- Subject is pregnant or lactating.
- Subject has a history of a bleeding disorder.
- Subject is taking an anti-coagulant.
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 |
|---|---|---|
| Universal PeelUniversal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol) | Drug | Microneedling Plus Universal Peel |
| MicroneedlingMicroneedling: is a device for all skin types that creates micro "injuries" in the dermis (layer of the skin underneath the outermost layer) in an attempt to trigger new collagen (natural component of skin tissue) production for smoother, firmer and younger-looking skin. For this protocol, the needle depth will be increased over the 3 sessions: Forehead: 0.75 mm, 0.85 mm, 1.0 mm. Cheeks/Chin: 1.0 mm, 1.5 mm, 2.0 mm. Each Session: Microneedling procedure on Day 1, followed by skin care regimen | Procedure or surgery | Microneedling Plus Universal Peel |
| Post-Microneedling Skin CareOn Day 1 (after Microneedling procedure): * Gentle Antioxidant Soothing Cleanser daily * Soothing Recovery Ointment and Sheer Physical Sunscreen On Day 2-7: * AM: Physical sheer sunscreen and recovery ointment * PM: Retinol/Vitamin C in the evening and soothing recovery ointment On Day 7: * AM: BD Hydrating Day/Night Cream * PM: Retinol and Vitamin C and the BD Hydrating Day/Night Cream (if necessary) | Drug | Microneedling Plus Universal Peel |
| Post-Universal Peel Skin Care* Gentle Antioxidant Soothing Cleanser daily * Physical Sunscreen daily * Soothing recovery ointment fortified with silver only when peeling occurs * After completely peeling, vitamin c product in the morning and the retinol in the evening | Drug | Microneedling Plus Universal Peel |
Primary outcome
Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.
Time frame: 6 months
The scale will be completed at every office visit over the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Improvement in the appearance of acne scarring as measured by the 4 Point Scar Scale.
Time frame: 6 Months
The scale will be completed at each office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).
Improvement in the appearance of acne scarring as measured by the Global Assessment.
Time frame: 6 months
The Global Assessment of Improvement will be completed at Week 17.
3 secondary outcomes
Improvement in the appearance of acne scarring as subjectively measured through digital pictures.
Time frame: 6 months
Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.
Time frame: 6 months
Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.
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 19 Feb 2016.
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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.
Naana Boakye, MD principal investigator
Englewood Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal Peel, Microneedling and Post-Microneedling Skin Care in people with Acne Scarring, run by Englewood Hospital and Medical Center at 1 site in United States.
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 3 inclusion and 8 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 19 Feb 2016. 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 United States. 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?
Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale. (time frame: 6 months). The study lists 3 primary outcomes in all. 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 19 Feb 2016.