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

Primary Purpose

Acne Vulgaris, Post Inflammatory Hyperpigmentation, Post Inflammatory Pigmentation Change

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tazarotene 0.045% Lotion
Sponsored by
Dr. Emmy Graber
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Post Inflammatory Hyperpigmentation, Post Inflammatory Pigmentation Change, Erythema, Acne scars

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient is male or female, 18-45 years of age inclusive at Screening. Must have a facial IGA score of 2,3, or 4. Minimum of 10 inflammatory lesions (papules, pustules, or nodules) in total on face (including nose). Minimum of 20 PIE or PIH macules in total on face (including nose). Skin phototype of I to VI on Fitzpatrick's scale. Female subjects of childbearing potential must be on one of the following forms of birth control: a hormonal or non-hormonal IUD, an oral contraceptive pill that contains both estrogen and progestin, a contraceptive implant, or Depo shot. Patients will remain on the same contraception for 90 days prior to the baseline visit, for the duration of the study and for 1 month after. Exclusion Criteria: More than 3 excoriated acne lesions. Beard or extensive facial hair. Female subject who is pregnant, nursing, or planning a pregnancy during the trial or within one month after last trial treatment application. Isotretinoin within 90 days. Other topical prescription retinoids (30 days wash out). A new hormone or hormone regulating therapy (such as spironolactone or birth control), or change in an existing dosage, for any reason within 90 days prior to screening. A patient who has been using the same regimen for more than 90 days prior to the study may be enrolled but is expected to remain on said regimen for the duration of the study. A new oral antibiotic or change in an existing dosage for any reason within 30 days prior to screening. A patient who has been using the same regiment for more than 30 days prior to the study may be enrolled but is expected to remain on the said regimen for the duration of the study. A new or change in topical anti-acne agents within 60 days of starting the study. This includes topical medications such as: benzoyl peroxide, erythromycin, clindamycin, minocycline, clascoterone, and dapsone. Use of such agents is permitted as long as subjects have been using these topical agents for at least 60 days prior and willing to stay on them for the duration of the study. Sebacia laser treatment within 180 days of study enrollment. Subjects may not have this treatment during the study. Any facial laser treatment or chemical peel within one month of enrollment. Subjects may not have these treatments during the study.

Sites / Locations

  • The Dermatology Institute of Boston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

This is a single arm study. All participants are receiving the treatment.

Outcomes

Primary Outcome Measures

Reduction of postinflammatory erythema lesion count.
A count of postinflammatory erythema lesions will be conducted at each visit.
Reduction of postinflammatory hyperpigmentation lesion count.
A count of postinflammatory hyperpigmentation lesions will be conducted at each visit.
Reduction of active acne lesion count
Active acne lesions will be counted at each visit.

Secondary Outcome Measures

Patient perceived improvement through completion of a patient satisfaction survey
The patient will fill out a questionnaire at each visit.

Full Information

First Posted
February 5, 2021
Last Updated
January 19, 2023
Sponsor
Dr. Emmy Graber
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1. Study Identification

Unique Protocol Identification Number
NCT05704114
Brief Title
Tazarotene 0.045% Lotion for Treating PIE and PIH in Subjects With Acne
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Emmy Graber

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Post Inflammatory Hyperpigmentation, Post Inflammatory Pigmentation Change, Erythema, Skin Scarring
Keywords
Acne vulgaris, Post Inflammatory Hyperpigmentation, Post Inflammatory Pigmentation Change, Erythema, Acne scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
This is a single arm study. All participants are receiving the treatment.
Intervention Type
Drug
Intervention Name(s)
Tazarotene 0.045% Lotion
Other Intervention Name(s)
Arazlo
Intervention Description
Daily topical use of tazarotene for 16 weeks.
Primary Outcome Measure Information:
Title
Reduction of postinflammatory erythema lesion count.
Description
A count of postinflammatory erythema lesions will be conducted at each visit.
Time Frame
16 weeks
Title
Reduction of postinflammatory hyperpigmentation lesion count.
Description
A count of postinflammatory hyperpigmentation lesions will be conducted at each visit.
Time Frame
16 weeks
Title
Reduction of active acne lesion count
Description
Active acne lesions will be counted at each visit.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Patient perceived improvement through completion of a patient satisfaction survey
Description
The patient will fill out a questionnaire at each visit.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient is male or female, 18-45 years of age inclusive at Screening. Must have a facial IGA score of 2,3, or 4. Minimum of 10 inflammatory lesions (papules, pustules, or nodules) in total on face (including nose). Minimum of 20 PIE or PIH macules in total on face (including nose). Skin phototype of I to VI on Fitzpatrick's scale. Female subjects of childbearing potential must be on one of the following forms of birth control: a hormonal or non-hormonal IUD, an oral contraceptive pill that contains both estrogen and progestin, a contraceptive implant, or Depo shot. Patients will remain on the same contraception for 90 days prior to the baseline visit, for the duration of the study and for 1 month after. Exclusion Criteria: More than 3 excoriated acne lesions. Beard or extensive facial hair. Female subject who is pregnant, nursing, or planning a pregnancy during the trial or within one month after last trial treatment application. Isotretinoin within 90 days. Other topical prescription retinoids (30 days wash out). A new hormone or hormone regulating therapy (such as spironolactone or birth control), or change in an existing dosage, for any reason within 90 days prior to screening. A patient who has been using the same regimen for more than 90 days prior to the study may be enrolled but is expected to remain on said regimen for the duration of the study. A new oral antibiotic or change in an existing dosage for any reason within 30 days prior to screening. A patient who has been using the same regiment for more than 30 days prior to the study may be enrolled but is expected to remain on the said regimen for the duration of the study. A new or change in topical anti-acne agents within 60 days of starting the study. This includes topical medications such as: benzoyl peroxide, erythromycin, clindamycin, minocycline, clascoterone, and dapsone. Use of such agents is permitted as long as subjects have been using these topical agents for at least 60 days prior and willing to stay on them for the duration of the study. Sebacia laser treatment within 180 days of study enrollment. Subjects may not have this treatment during the study. Any facial laser treatment or chemical peel within one month of enrollment. Subjects may not have these treatments during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmy Graber
Organizational Affiliation
The Dermatology Insitutue of Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Dermatology Institute of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28686774
Citation
Tan J, Bourdes V, Bissonnette R, Petit B Eng L, Reynier P, Khammari A, Dreno B. Prospective Study of Pathogenesis of Atrophic Acne Scars and Role of Macular Erythema. J Drugs Dermatol. 2017 Jun 1;16(6):566-572.
Results Reference
background
PubMed Identifier
20981308
Citation
Fabbrocini G, Annunziata MC, D'Arco V, De Vita V, Lodi G, Mauriello MC, Pastore F, Monfrecola G. Acne scars: pathogenesis, classification and treatment. Dermatol Res Pract. 2010;2010:893080. doi: 10.1155/2010/893080. Epub 2010 Oct 14.
Results Reference
result

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

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