Trifarotene Cream for Acne

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Galderma Investigational Site #9928, Boynton Beach, FL
Acne
Trifarotene Cream - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a cream containing a drug can help prevent scars from forming.

See full description

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Trifarotene Cream will improve 1 primary outcome and 2 secondary outcomes in patients with Acne. Measurement will happen over the course of Baseline upto Week 20.

Baseline upto Week 20
Absolute Change from Baseline in Total Atrophic Acne Scar Count Per Half-Face to Week 20
Baseline upto Week 24
Total Atrophic Acne Scar Count Per Half-Face From Baseline to Week 24
Baseline, Week 24
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Trifarotene (CD5789) 50 mcg/g Cream
1 of 2
Trifarotene Vehicle Cream
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 118 total participants across 2 different 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.

Trifarotene (CD5789) 50 mcg/g Cream
Drug
Trifarotene Vehicle Cream
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, week 24 for reporting.

Closest Location

Galderma Investigational Site #9928 - Boynton Beach, FL

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face;
A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side;
No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on the face;
A minimum of 10 atrophic acne scars in total (>2 mm)
Inflammatory and non-inflammatory lesions;
Atrophic acne scars (minimum of 4 scars per half-face)
The participant is a female of non-childbearing potential
If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris
Other protocol defined inclusion criteria could apply
Key

Patient Q&A Section

What causes acne?

"There are a wide range of causes of acne, many of which are still completely unclear. The main causes are of skin infection, hormonal and environmental factors." - Anonymous Online Contributor

Unverified Answer

What are the signs of acne?

"The appearance of acne depends upon whether the acne is caused by a predisposition or by a local irritant. The presence of visible crusting and erythema are excellent" - Anonymous Online Contributor

Unverified Answer

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

"A majority of adults aged 18 to 34 years old have acne. More than 50 percent of men and women aged 15 to 24 years had acne at some point before the study." - Anonymous Online Contributor

Unverified Answer

Can acne be cured?

"Achieving sustained improvement with topical medications has not been proven in any randomized controlled trial in the acne population. A variety of topical therapies have shown topical treatments (e.g., benzoyl peroxide, retinoids, etc.) to be safe, effective, and relatively inexpensive when used appropriately." - Anonymous Online Contributor

Unverified Answer

What are common treatments for acne?

"The most common treatment for acne is isotretinoin. The use of other medications, including benzoyl peroxide, has been declining. Topical bleaching agents, such as hydroquinone, are also commonly used to treat acne." - Anonymous Online Contributor

Unverified Answer

What is acne?

"There is no significant correlation between acne and skin color in the United Arab Emirates. No acne-prone skin type (dryness, oilyness and sensitivity to sunlight) has been mentioned in the available literature. There is a slight bias noted towards a female bias. The majority of patients (90%) reported that they take medication to control their facial acne, which often requires multiple treatments." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating acne?

"In the last decade, acne treatments have become much improved and more convenient. The cosmetic dermatologist can still offer the best solutions and care of this old skin disease. This, in turn, will help improving patients' life quality." - Anonymous Online Contributor

Unverified Answer

Is trifarotene cream safe for people?

"In a retrospective review of 1088 patients treated with trifarotene, the most commonly reported side effects were skin and scalp redness, dryness, itching, and scalp hair loss. However, none of these side effects was serious or permanent. Trifarotene appears to be safe for use in patients with acne and does not interfere with birth control usage." - Anonymous Online Contributor

Unverified Answer

Has trifarotene cream proven to be more effective than a placebo?

"Trifarotene cream is effective in the treatment of acne vulgaris and may be more effective than a placebo cream especially in patients with acne vulgaris with poor acanthosis nigricans. As a conclusion, trifarotene cream appears to be effective in treating acne vulgaris and should be considered as a treatment option in patients with poor acanthosis nigricans." - Anonymous Online Contributor

Unverified Answer

What does trifarotene cream usually treat?

"Trifarotene cream is a common treatment for erythematous [acne scar](https://www.withpower.com/clinical-trials/acne-scar)s and telogen effluvium in the outpatient setting. No major side effects are often associated with its use, except a few instances of temporary tingling sensations and minor skin irritation. However, trifarotene does not treat acne per se, although it may be helpful in the symptomatic relief of acne scars and telogen effluvium. Topical treatment options of the aforementioned conditions, such as tretinoin, are usually much more effective and lasting in the long term than prescription anti-acne and anti-inflammatory medicines." - Anonymous Online Contributor

Unverified Answer

What is trifarotene cream?

"Trifarotene has potent antiviral activity against influenza viruses A and B and is a first generation retinoid. Trifarotene (4[(4′-(4′-methylphenylcarbamoyl) oxycarbonyl)oxy-2-methoxybenzyl]phenyl)retinoic acid is a synthetic retinoid." - Anonymous Online Contributor

Unverified Answer

How does trifarotene cream work?

"Trifarotene is an effective and versatile acne treatment that can resolve acne in several different ways, depending on the severity of the disease: by inducing clearance or by reducing the acne phenotype (for a long time), or both. There was a tendency, however, for those subjects receiving trifarotene cream to get a less favorable treatment outcome when compared to those taking placebo or a combination of trifarotene and topical benzoyl peroxide, or oral isotretinoin." - Anonymous Online Contributor

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