An In Vivo Model for Postinflammatory Hyperpigmentation
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Post-inflammatory Hyperpigmentation||Drug: Tricholoacetic Acid (TCA)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- validate a quality of life questionnaire for post-inflammatory hyperpigmentation. [ Time Frame: 35 days ]Administration of PIH surveys
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): NCT02905903
|Contact: Angela Parks-Millerfirstname.lastname@example.org|
|Contact: Indermeet Kohli, Ph.Demail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Iltefat Hamzavi, MD||Henry Ford Hospital|