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

NCT05704114 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: DIB-0201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Reduction of postinflammatory erythema lesion count.

  A count of postinflammatory erythema lesions will be conducted at each visit.

  16 weeks

• Reduction of postinflammatory hyperpigmentation lesion count.

  A count of postinflammatory hyperpigmentation lesions will be conducted at each visit.

  16 weeks

• Reduction of active acne lesion count

  Active acne lesions will be counted at each visit.

  16 weeks

Secondary Outcomes (1)

• Patient perceived improvement through completion of a patient satisfaction survey

  16 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Drug: Tazarotene 0.045% Lotion

Interventions

Tazarotene 0.045% Lotion DRUG

Daily topical use of tazarotene for 16 weeks.

Also known as: Arazlo

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Emmy Graber: lead

Study Sites (1)

The Dermatology Institute of Boston

Boston, Massachusetts, 02116, United States

Location

Related Publications (2)

• 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.

  PMID: 28686774 BACKGROUND

• 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.

  PMID: 20981308 RESULT

MeSH Terms

Conditions

Acne Vulgaris; Hyperpigmentation; Erythema; Cicatrix

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pigmentation Disorders; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Study Officials

• Emmy Graber

  The Dermatology Insitutue of Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of The Dermatology Institute of Boston, Principal Investigator

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: January 30, 2023
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

US (1)