Acne VulgarisPhase 4NCT05704114
Tazarotene 0.045% Lotion for Treating PIE and PIH in Subjects With Acne
A Phase 4 study testing Tazarotene 0.045% Lotion in people with Acne Vulgaris and Post Inflammatory Hyperpigmentation, run by Dr. Emmy Graber at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Post Inflammatory Hyperpigmentation, Post Inflammatory Pigmentation Change
- What is being tested?
- Tazarotene 0.045% Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Dermatology Institute of Boston
Boston, Massachusetts, 02116
About this study
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
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.
Read the 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.
- Conditions
- Acne Vulgaris, Post Inflammatory Hyperpigmentation, Post Inflammatory Pigmentation Change, Erythema, Skin Scarring
- Being tested
- Tazarotene 0.045% Lotion
- Keywords
- Acne vulgaris, Post Inflammatory Hyperpigmentation, Post Inflammatory Pigmentation Change, Erythema, Acne scars
- Medical subject headings
- Acne Vulgaris, Hyperpigmentation, Erythema, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tazarotene 0.045% LotionDrug
Also called Arazlo
Daily topical use of tazarotene for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | This is a single arm study. All participants are receiving the treatment. Receives: Drug: Tazarotene 0.045% Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of postinflammatory erythema lesion count.
A count of postinflammatory erythema lesions will be conducted at each visit.
Measured: 16 weeks
Reduction of postinflammatory hyperpigmentation lesion count.
A count of postinflammatory hyperpigmentation lesions will be conducted at each visit.
Measured: 16 weeks
Reduction of active acne lesion count
Active acne lesions will be counted at each visit.
Measured: 16 weeks
Secondary outcomes (1)
Patient perceived improvement through completion of a patient satisfaction survey
The patient will fill out a questionnaire at each visit.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2021
- Primary completion1 Feb 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Emmy Graber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Emmy Graber, The Dermatology Institute of Boston
- Investigators
- Emmy Graber, Principal investigator, The Dermatology Insitutue of Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704114
- Sponsor's protocol ID
- DIB-0201
- Status last verified
- Jan 2023
- First submitted
- 5 Feb 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 28686774Fabbrocini 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.
PubMed 20981308
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05704114
- Acronym / sponsor ID
- DIB-0201
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr. Emmy GraberUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Tazarotene 0.045% LotionThis is a single arm study. All participants are receiving the treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tazarotene 0.045% LotionAlso: ArazloDaily topical use of tazarotene for 16 weeks. | Drug | Treatment Arm |
Primary outcome
Reduction of postinflammatory erythema lesion count.
Time frame: 16 weeks
A count of postinflammatory erythema lesions will be conducted at each visit.
Reduction of postinflammatory hyperpigmentation lesion count.
Time frame: 16 weeks
A count of postinflammatory hyperpigmentation lesions will be conducted at each visit.
Reduction of active acne lesion count
Time frame: 16 weeks
Active acne lesions will be counted at each visit.
1 secondary outcome
Patient perceived improvement through completion of a patient satisfaction survey
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 28686774Tan 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 publication: PubMed 20981308Fabbrocini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmy Graber principal investigator
The Dermatology Insitutue of Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tazarotene 0.045% Lotion in people with Acne Vulgaris and Post Inflammatory Hyperpigmentation, run by Dr. Emmy Graber at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of postinflammatory erythema lesion count. (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704114, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.