An In Vivo Model for Postinflammatory Hyperpigmentation

NCT02905903 | Completed

• 1 other identifier: IRB #9920 Protocol 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-inflammatory Hyperpigmentation

Outcome Measures

Primary Outcomes (3)

• Optimal TCA concentration for induction of post-inflammatory hyperpigmentation

  This will be determined by comparing acne induced PIH and the different concentrations of TCA induced PIH

  35 days

• Study genetic components of post-inflammatory hyperpigmentation by evaluating single nucleotide polymorphism and microRNA

  These will be evaluated by blood draws and biopsy

  35 days

• Study individual risk factors for those susceptible to developing postinflammatory hyperpigmention

  These will be evaluated by surveys and comparing subjects with PIH versus no PIH

  35 days

Secondary Outcomes (1)

• validate a quality of life questionnaire for post-inflammatory hyperpigmentation.

  35 days

Study Arms (1)

Trichloroacetic Acid

OTHER

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)

Interventions

Tricholoacetic Acid (TCA) DRUG

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.

Trichloroacetic Acid

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,

Detroit, Michigan, 48202, United States

Location

Related Publications (6)

• Taylor S, Grimes P, Lim J, Im S, Lui H. Postinflammatory hyperpigmentation. J Cutan Med Surg. 2009 Jul-Aug;13(4):183-91. doi: 10.2310/7750.2009.08077.

  PMID: 19706225 BACKGROUND

• Davis EC, Callender VD. Postinflammatory hyperpigmentation: a review of the epidemiology, clinical features, and treatment options in skin of color. J Clin Aesthet Dermatol. 2010 Jul;3(7):20-31.

  PMID: 20725554 BACKGROUND

• Baumann L, Rodriguez D, Taylor SC, Wu J. Natural considerations for skin of color. Cutis. 2006 Dec;78(6 Suppl):2-19.

  PMID: 17354519 BACKGROUND

• Grimes PE, Stockton T. Pigmentary disorders in blacks. Dermatol Clin. 1988 Apr;6(2):271-81.

  PMID: 3378372 BACKGROUND

• Motokawa T, Kato T, Hashimoto Y, Katagiri T. Effect of Val92Met and Arg163Gln variants of the MC1R gene on freckles and solar lentigines in Japanese. Pigment Cell Res. 2007 Apr;20(2):140-3. doi: 10.1111/j.1600-0749.2007.00364.x.

  PMID: 17371441 BACKGROUND

• Szell M, Baltas E, Bodai L, Bata-Csorgo Z, Nagy N, Dallos A, Pourfarzi R, Simics E, Kondorosi I, Szalai Z, Toth GK, Hunyadi J, Dobozy A, Kemeny L. The Arg160Trp allele of melanocortin-1 receptor gene might protect against vitiligo. Photochem Photobiol. 2008 May-Jun;84(3):565-71. doi: 10.1111/j.1751-1097.2008.00296.x. Epub 2008 Feb 11.

  PMID: 18282185 BACKGROUND

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Iltefat Hamzavi, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Physician

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: February 14, 2016
• Primary Completion: May 16, 2018
• Study Completion: June 21, 2019
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)