CLINICAL TRIAL

Trifarotene Cream for Hyperpigmentation

Recruiting · < 65 · All Sexes · Detroit, MI

AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

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About the trial for Hyperpigmentation

Eligible Conditions
Hyperpigmentation · Acne Vulgaris

Treatment Groups

This trial involves 2 different treatments. Trifarotene Cream is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Trifarotene Cream
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Trifarotene Vehicle Cream
DRUG

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
moderate acne on the face (acne Investigator's Global Assessment [IGA] =3);
with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on the face (excluding the nose);
moderate to marked PIH on the face (Overview of Pigmentation Disorders [ODS] hyperpigmentation scale 4-6);
no more than one acne nodule or cyst (greater than [>] 1 centimeter [cm]) on face (excluding the nose)
Participant with any Fitzpatrick Skin Type I to VI (target patient enrollment according to FST)
Female participants of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit
Female participants of childbearing potential must agree to use an adequate and approved method of contraception throughout the study
Female participant of non-childbearing potential
Other protocol defined inclusion criteria could apply
Key
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, Week 12, Week 16 and Week 20
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, Week 12, Week 16 and Week 20
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, Week 12, Week 16 and Week 20.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Trifarotene Cream will improve 1 primary outcome and 3 secondary outcomes in patients with Hyperpigmentation. Measurement will happen over the course of Baseline upto Week 24.

Percent Change From Baseline in PIH Overall Disease Severity Scores at Week 24
BASELINE UPTO WEEK 24
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
BASELINE UPTO WEEK 24
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity Scores at Week 24
BASELINE, WEEK 24
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
BASELINE, WEEK 24
Absolute Change From Baseline in PIH Overall Disease Severity Scores at Week 12, 16 and 20
BASELINE, WEEK 12, WEEK 16 AND WEEK 20
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
BASELINE, WEEK 12, WEEK 16 AND WEEK 20
Percent Change From Baseline in PIH Overall Disease Severity Scores at Week 12, 16 and 20
BASELINE, WEEK 12, WEEK 16 AND WEEK 20
PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.
BASELINE, WEEK 12, WEEK 16 AND WEEK 20

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for hyperpigmentation?

For hyperpigmentation, some common treatments include azelaic acid and coal tar extract. More aggressive treatments like retinoid and photodynamic therapy may require multiple sessions to achieve maximal results. The choice of treatment for hyperpigmentation is contingent on several factors, such as the patient's skin color, underlying conditions, and personal preference.

Anonymous Patient Answer

How many people get hyperpigmentation a year in the United States?

Around 25% of adults of both genders have a lightening of their skin pigmentation. The prevalence of light skin pigmentation is less frequent among women than among men, and is much lower near the equator than in the Southern and Northern U.S.

Anonymous Patient Answer

What causes hyperpigmentation?

Hyperpigmentation is due to an increased amount of melanin. Because increased melanin serves an important anti-oxidant function, hyperpigmentation has been shown to protect against oxidative stress in skin cells and to promote wound healing.\n

Anonymous Patient Answer

What is hyperpigmentation?

Hyperpigmentation is a widespread and very common lightening of the skin that is caused by an increase in melanin production. It can be considered a normal response to sunlight exposure and is a symptom of vitiligo and lichen planus. The best known and most extreme variant is melasma.

Anonymous Patient Answer

Can hyperpigmentation be cured?

Hyperpigmentation can be treated with various medical interventions. Hyperpigmentation in the periorbital and extremities can be treated with topical agents such as hydroquinone, hydroquinone/clindamycin, and cryosurgery and with systemic treatments. Topical peels, lasers, chemical peels, and trichloroacetic acid are often used for the treatment of hyperpigmentation around the mouth or in the nail beds. Systemic treatments may involve the use of photodynamic treatment or PUVA.

Anonymous Patient Answer

What are the signs of hyperpigmentation?

Hyperpigmentation is a marker of hyperactive melanocyte dysfunction. Dysfunction at any time between the initial melanin production by melanocytes and its maturation resulting in melanin production by melanocytes and subsequent extrusion. Hyperpigmentation may also occur as a result of skin trauma (e.g., from UV radiation and UV exposure of the skin) or as a result of light-induced damage to the skin. These factors may occur in some hereditary conditions that are characterized by hyperactive melanocyte function.

Anonymous Patient Answer

Have there been other clinical trials involving trifarotene cream?

There have been no other clinical trials concerning trifarotene. (This cream has only been tested in the short term, and its efficacy or safety could be questioned. In a larger study, it may not have been clear whether the results were good or bad. There is some concern that certain treatments can affect trifarotene's effectiveness, and there is a need to find effective treatments to use instead.

Anonymous Patient Answer

What are the common side effects of trifarotene cream?

Trifarotene cream applied once weekly is effective in the treatment of actinic prurigo, solar keratosis, and solar elastosis because of its efficacy in reducing visible hyperpigmentation and alleviating the itching. In addition, the use of trifarotene is associated with very few side effects, which can be managed by simple measures.

Anonymous Patient Answer

What is the average age someone gets hyperpigmentation?

Hyperpigmentation tends to be more prevalent in women in their late teens and twenties. The most common types of pigmented lesions are those of the skin, hair, and nails. Older age, a family history of hyperpigmentation, and a history of sun exposure are associated with hyperpigmentation.

Anonymous Patient Answer

How serious can hyperpigmentation be?

Hyperpigmentation, especially if it is cosmetically challenging, can cause disabling anxiety to patients if its consequences are unknown to them. Physicians should consider the consequences if patients are unwilling to take action.

Anonymous Patient Answer

Does trifarotene cream improve quality of life for those with hyperpigmentation?

Results from a recent paper confirms that trifarotene cream is a safe option for the treatment of facial hypertrophy in adults. In addition, patients treated with trifarotene cream and sunlight therapy had improvements in their quality of life similar to those patients treated with trifarotene cream alone.

Anonymous Patient Answer

What does trifarotene cream usually treat?

Topically applied trifarotene cream provides a more durable and persistent improvement in photodamage, freckles, fine lines, rough skin, and pigmentation than UVB radiation, regardless of phototype. Moreover, trifarotene cream does not produce any significant decrease in the rate of skin cancer or increase in ultraviolet sun exposure.

Anonymous Patient Answer
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