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

• Status: Completed
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Emmy Graber
• Treatments: Tazarotene

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.