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Microneedling Plus the Universal Peel For Acne Scarring

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ClinicalTrials.gov Identifier: NCT02174393
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : February 19, 2016
Sponsor:
Collaborators:
Topix Pharmaceuticals
Eclipse Aesthetics
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Acne Scarring Drug: Universal Peel Procedure: Microneedling Drug: Post-Microneedling Skin Care Drug: Post-Universal Peel Skin Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI
Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: Microneedling Plus Universal Peel

(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.

Drug: Universal Peel
Universal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol)

Procedure: Microneedling

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


Drug: Post-Microneedling Skin Care

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)

Drug: 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




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. Improvement in the appearance of acne scarring as subjectively measured through digital pictures. [ Time Frame: 6 months ]
    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).

  2. Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index. [ Time Frame: 6 months ]
    The Cardiff Index will be completed at Baseline and Week 17.

  3. Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires. [ Time Frame: 6 months ]
    Subject will complete a pre-treatment questionnaire at Baseline and post-treatment questionnaires at Weeks 7 and 17.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174393


Locations
United States, New Jersey
Bergen Dermatology
Englewood Cliffs, New Jersey, United States, 07632
Sponsors and Collaborators
Englewood Hospital and Medical Center
Topix Pharmaceuticals
Eclipse Aesthetics
Investigators
Principal Investigator: Naana Boakye, MD Englewood Hospital and Medical Center

Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT02174393     History of Changes
Other Study ID Numbers: E-14-555
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes