COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

An In Vivo Model for Postinflammatory Hyperpigmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02905903
Recruitment Status : Unknown
Verified February 2017 by Iltefat Hamzavi, Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : September 19, 2016
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System

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.

Condition or disease Intervention/treatment Phase
Post-inflammatory Hyperpigmentation Drug: Tricholoacetic Acid (TCA) Not Applicable

Detailed Description:

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 evaluated miRNAs profiles in acne- induced PIH, TCA- induced PIH and normal skin. The investigators have defined some miRNAs that potentially are involved in PIH development and may be also serve as the biomarkers for PIH. The investigators found that there were 19 miRNA changes in acne-induced PIH versus normal skin, while 43 miRNA changes in TCA-inducedPIH versus normal skin. Interestingly, about 80% changed genes in acne were included in TCA-mediated miRNA changes, suggesting TCA can partially mimic acne-PIH.

Overall, this initial model for PIH, using TCA, serves as a foundation to better understand and improve our ability to manage PIH. In this next phase of the study, the investigators will refine this in vivo model for PIH by determining the optimal concentration of TCA to induce PIH.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An In Vivo Model for Postinflammatory Hyperpigmentation: Part II
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Trichloroacetic Acid
Intervention-Apply 4 concentrations of TCA (20%, 25%, 30%, 35%) to the buttocks to two spots each (total of 8 lesions) and following characteristics of these lesions and comparing them to acne induced PIH during the course of the study. Comparisons will be made using Investigators Global Assessment scoring of hyperpigmentation and erythema, colorimetry, photography, and biopsies
Drug: Tricholoacetic Acid (TCA)
We will be applying 4 concentrations of TCA (20%, 25%, 30%, 35%) to the buttocks to two spots each (total of 8 lesions) and following characteristics of these lesions and comparing them to acne induced PIH during the course of the study.

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

Secondary Outcome Measures :
  1. validate a quality of life questionnaire for post-inflammatory hyperpigmentation. [ Time Frame: 35 days ]
    Administration of PIH surveys

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with types I-VI skin
  • Minimum age of 18 years
  • Able to understand requirements of the study and risks involved
  • Able to sign a consent form.
  • Existing truncal acne pustules (at least two on the trunk) with or without history of post-inflammatory hyperpigmentation

Exclusion Criteria:

  • Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of PIH judged to be clinically significant by the investigator
  • Patients with a history of keloids
  • Patients with a history of cystic acne or acne conglobata
  • Patients on systemic antibiotics or keratolytics (isotretinoin, etc), or topical antibiotics or keratolytic use (retinoids, benzoyl peroxide) over target areas who are unwilling to stop these medications for the duration of the study.

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 identifier (NCT number): NCT02905903

Layout table for location contacts
Contact: Angela Parks-Miller 313-916-6964
Contact: Indermeet Kohli, Ph.D 313-916-6964

Layout table for location information
United States, Michigan
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard, Recruiting
Detroit, Michigan, United States, 48202
Contact: Angela Parks-Miller    313-916-6964   
Sponsors and Collaborators
Henry Ford Health System
Layout table for investigator information
Principal Investigator: Iltefat Hamzavi, MD Henry Ford Hospital
Layout table for additonal information
Responsible Party: Iltefat Hamzavi, Senior Staff Physician, Henry Ford Health System Identifier: NCT02905903    
Other Study ID Numbers: IRB #9920 Protocol 1
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pigmentation Disorders
Skin Diseases