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OpenTrials
Completed

NCT Number: NCT02174393

Microneedling Plus the Universal Peel For Acne Scarring

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.

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Key information

Conditions

Acne Scarring

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bergen Dermatology

Englewood Cliffs, New Jersey, 07632, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Universal Peel

Drug

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

Microneedling

Procedure

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 Care

Drug

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 Care

Drug
  • 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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Collaborators

  • Eclipse Aesthetics
  • Topix Pharmaceuticals

Registry information

Official study title

Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2014
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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