Tazarotene 0.045% Lotion for Treating PIE and PIH in Subjects With Acne

Acne Vulgaris Clinical Trial

Official title: A Prospective, Single-center, Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Tazarotene 0.045% Lotion (Arazlo) for Treating Postinflammatory Erythema and Postinflammatory Hyperpigmentation in Subjects With Acne

Status Completed

Clinical Trial Summary

The purpose of the study is to assess the safety and efficacy of Arazlo Lotion (Tazarotene 0.045% Lotion) for treatment of postinflammatory erythema and postinflammatory hyperpigmentation in subjects with acne.

Clinical Trial Description

This research study is studying Arazlo Lotion (Tazarotene 0.045% Lotion) as a possible treatment for treating postinflammatory erythema (skin reddening) and postinflammatory hyperpigmentation (dark skin spots) secondary to acne. Up to 20 people at the study doctor's office will be enrolled. Bausch Health USA is manufacturing the study drug in this research study.

The participants are being asked to participate in this research study because the participants have postinflammatory erythema and/or postinflammatory hyperpigmentation secondary to acne.

Postinflammatory erythema (PIE) is defined as the blanchable (turns white when pressed) red or pink macule (discolored spot) seen after an acne lesion (skin sore) resolves. PIE has been considered to be stage I scarring by some; however, PIE is not permanent but may be the preceding lesion for some atrophic (indented) scars. PIE is exceedingly common and is seen more in lighter skin types (I-III) and is often incorrectly considered by health care providers to be hyperpigmentation. PIE is nearly ubiquitous in acne patients with fairer skin tones and is blanchable erythema rather than hyperpigmentation. It differs from postinflammatory hyperpigmentation (PIH), which is the formation of dark macules due to an overexpression of melanin (dark pigment) that is secondary to an inflammatory response. PIH is particularly common in dark-skinned individuals.

PIE has been reportedly treated with in office treatments such as: pulsed dye laser, 1,450-nm laser, or fractional microneedling with radiofrequency; however, these treatments are not perfect. They come at a high financial cost to the patient, are not without side effects, are not well studied, and their efficacy for PIE is questionable. There is no known topical treatment for PIE that is secondary to acne. Conversely, various topicals do exist to treat PIH that work by inhibiting tyrosinase (an enzyme responsible for the first step in producing melanin), such as topical retinoids (compounds similar to Vitamin A). One small study showed tazarotene 0.1% cream to be effective in improving PIH. However, there are also reports of tazarotene worsening PIH, likely due to the skin irritation caused by the high strength of the tazarotene.

Our intended purpose is to demonstrate that Arazlo Lotion can reduce the formation of PIE and PIH in acne patients. The investigators hypothesize that Arazlo Lotion prevents the formation of PIE and PIH and treats PIE and PIH from acne due to its anti-inflammatory properties. These same anti-inflammatory properties of topical retinoids have been proven to reduce active acne lesions. However, no one has investigated the role of Arazlo Lotion on PIE and PIH. Small studies have shown that tazarotene 0.1% have improved PIH but other case reports have shown it to cause PIH. Utilizing Arazlo Lotion, a lower strength of tazarotene, in a gentler formulation, the investigators believe will lessen PIH without causing irritation and therefore reduce any potential PIH sequelae (conditions).

A participant cannot join this study if the participant has more than 3 excoriated (picked lesions) acne lesions, a beard or extensive facial hair, are a female subject who is pregnant, nursing, or planning a pregnancy during the trial, or the study doctor feels the participant needs to be treated with acne medications that are taken by mouth (also called "oral" medications). This is a study for subjects with discoloration, PIE and PIH, secondary to acne. The goal of treatment in this study is for the participant's acne discoloration to improve, which is no different than if the participant were to see the study doctor without being in the study.

The participant will receive the study drug, Arazlo Lotion, and any other topicals (applied on the skin) required by the study and all study examinations at no charge. The participant will receive payment to cover the costs of the participant's time and expenses to go to the study doctor's office for the study. ;

Related Conditions & MeSH terms

• Acne Vulgaris
• Cicatrix
• Erythema
• Hyperpigmentation
• Post Inflammatory Hyperpigmentation
• Skin Scarring

• NCT number: NCT05704114
• Study type: Interventional
• Source: The Dermatology Institute of Boston
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2021
• Completion date: May 1, 2022