Clinical Trial: An In Vivo Model for Postinflammatory Hyperpigmentation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An In Vivo Model for Postinflammatory Hyperpigmentation: Part II

Brief Summary: Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after cutaneous inflammation or injury that frequently affects darker skinned populations. Previously, a model of 35% TCA-induced PIH was validated against acne induced PIH, which has value in product testing for the treatment of PIH. In this second phase of the study, the investigators would like to determine if a lower concentration of TCA-induced PIH is comparable to acne-induced PIH.

Detailed Summary:

Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after cutaneous inflammation or injury. This process can occur in all skin types but more frequently affects darker skinned patients, such as African-Americans, Hispanics, Asians, Native Americans, Pacific Islanders and those of Middle Eastern descent. PIH can occur after infection, allergic reactions, contact dermatitis, some medications, burns, following procedures, or inflammatory disease such as acne. In skin of color, PIH frequently occurs in resolving acne lesions and can persist for months after the acne lesion itself has disappeared. In many cases, the resulting PIH can be more distressing than the original insult.

During the first phase of this study, the investigators investigated the clinical, spectroscopic and histologic characteristics of acne-induced PIH versus irritant induced PIH using Trichloroacetic acid (TCA), 35% solution. From this initial study, the investigators concluded that the similarity of Investigator's Global Assessment scores, and spectroscopic measurements using Diffuse Reflectance Spectroscopy and Colorimetry in both acne and TCA-induced PIH at Day 28 suggest that TCA-induced PIH could be a reproducible model for acne induced PIH.

MicroRNAs (miRNAs) are a class of small non-coding RNA molecules that regulate the expression of multiple genes at the post-transcriptional level through degradation and translation of target mRNAs. In the initial study, the investigators hypothesized that miRNAs derived from melanocytes and immune cells during PIH development could be detected in tissue and serve as novel biomarkers for PIH and making appropriate therapeutic decisions. To test this hypothesis, the investigators first examined miRNA gene expression profiles during PIH development using different models, and then ev
Sponsor: Henry Ford Health System

Current Primary Outcome:

  • Optimal TCA concentration for induction of post-inflammatory hyperpigmentation [ Time Frame: 35 days ]
    This will be determined by comparing acne induced PIH and the different concentrations of TCA induced PIH
  • Study genetic components of post-inflammatory hyperpigmentation by evaluating single nucleotide polymorphism and microRNA [ Time Frame: 35 days ]
    These will be evaluated by blood draws and biopsy
  • Study individual risk factors for those susceptible to developing postinflammatory hyperpigmention [ Time Frame: 35 days ]
    These will be evaluated by surveys and comparing subjects with PIH versus no PIH


Original Primary Outcome: Same as current

Current Secondary Outcome: validate a quality of life questionnaire for post-inflammatory hyperpigmentation. [ Time Frame: 35 days ]

Administration of PIH surveys


Original Secondary Outcome: Same as current

Information By: Henry Ford Health System

Dates:
Date Received: September 14, 2016
Date Started: February 2016
Date Completion: December 2017
Last Updated: February 22, 2017
Last Verified: February 2017