Related Experiment Video
Updated: Nov 3, 2025
Author Spotlight: Advancing Facial Rejuvenation Therapy with Post-Laser Salicylic Acid Application
Published on: September 27, 2024
Evaluation of a First-in-Class Proteasome Inhibitor in Patients With Moderate to Severe Rosacea
Background:
Novel, effective, affordable therapies for rosacea are needed. Innovative methods of assessing response for rosacea treatments are needed as well. This trial was designed to evaluate efficacy and safety of ACU-D1, a novel inhibitor of the 26S protea-some for the treatment of moderate to severe rosacea in a first in human pilot study. In addition, this is the first trial to our knowledge to use Canfield imaging to quantitatively assess responses.
Methods:
This was a 14-week, randomized, double-blinded, placebo-controlled study, performed at two well established rosacea clini-cal trial sites, which randomized 40 adult subjects with moderate to severe rosacea (Investigator’s Global Assessment [IGA]=3/4) to either ACU-D1 (27) or comparator vehicle (13) twice daily. In addition, Canfield imaging was used to assess responses both qualitatively and quantitatively Results: A total of 39 subjects participated, with 38 completing the study. ACU-D1 displayed efficacy in 92% (25 of 27) of patients in reducing inflammatory lesions and a 2 plus grade IGA reduction of clear to near clear in 27% of patients. There was a trend toward improvement in erythema as well in the active arm.
Conclusion:
This study demonstrates that topical ACU-D1 is safe and well-tolerated by patients in the study and demonstrates efficacy in reducing inflammatory lesions and erythema in patients with rosacea. Improvement was also noted on Canfield imaging, and this modality is likely to be used as an objective measure in the future. Further studies are warranted based on these initial positive results. ClinicalTrials.gov Identifier: NCT03064438 J Drugs Dermatol. 2021;20(6):660-664. doi:10.36849/JDD.5925.
Insights
This pilot study found topical ACU-D1 safe and effective for moderate to severe rosacea, significantly reducing inflammatory lesions. Canfield imaging also showed improvement, suggesting its utility for objective rosacea treatment assessment.
Area of Science:
- Dermatology
- Pharmacology
- Clinical Trials
Background:
- Need for novel, affordable rosacea therapies.
- Requirement for innovative response assessment methods.
- ACU-D1, a 26S proteasome inhibitor, is a potential novel topical treatment.
Purpose of the Study:
- Evaluate the safety and efficacy of ACU-D1 for moderate to severe rosacea.
- Conduct a first-in-human pilot study of ACU-D1.
- Utilize Canfield imaging for quantitative response assessment.
Main Methods:
- 14-week, randomized, double-blind, placebo-controlled study.
- 40 adult subjects with moderate to severe rosacea (IGA=3/4) randomized to ACU-D1 (n=27) or vehicle (n=13).
- Twice-daily topical application; Canfield imaging for qualitative and quantitative assessment.
Main Results:
- ACU-D1 demonstrated efficacy in 92% of patients, reducing inflammatory lesions.
- 27% of patients achieved a 2-grade Investigator's Global Assessment (IGA) reduction (clear to near clear).
- A trend toward improvement in erythema was observed in the ACU-D1 group.
Conclusions:
- Topical ACU-D1 is safe and well-tolerated in rosacea patients.
- ACU-D1 shows efficacy in reducing inflammatory lesions and erythema.
- Canfield imaging shows promise as an objective measure for rosacea treatment response.
