Clinical trial NCT02174393: Microneedling Plus the Universal Peel For Acne Scarring
Official title: Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scarring
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
Collaborators: name: Topix Pharmaceuticals
name: Eclipse Aesthetics
First posted: 2014-06-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.
timeFrame: 6 months
measure: Improvement in the appearance of acne scarring as measured by the 4 Point Scar Scale.
timeFrame: 6 Months
measure: Improvement in the appearance of acne scarring as measured by the Global Assessment.
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in the appearance of acne scarring as subjectively measured through digital pictures.
timeFrame: 6 months
measure: Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.
timeFrame: 6 months
measure: Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.
timeFrame: 6 months
Other outcomes:
Locations:
city: Englewood Cliffs
country: United States
facility: Bergen Dermatology
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Naana Boakye, MD
role: PRINCIPAL_INVESTIGATOR
References: