Tazarotene 0.045% Lotion for Treating PIE and PIH in Subjects With Acne
Condition: Acne Vulgaris; Post Inflammatory Hyperpigmentation; Post Inflammatory Pigmentation Change; Erythema; Skin Scarring
MeSH terms: Acne Vulgaris; Erythema; Hyperpigmentation; Cicatrix
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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.
    

Intervention name(s): Tazarotene 0.045% Lotion
Intervention type(s): Drug
Intervention description(s): Daily topical use of tazarotene for 16 weeks.
Other intervention name(s): Arazlo
Intervention MeSH terms: Tazarotene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne vulgaris; Post Inflammatory Hyperpigmentation; Post Inflammatory Pigmentation Change; Erythema; Acne scars