The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are:
* The maximum tolerated dose of ACU-D1
* Safety and tolerability of topical ACU-D1
* Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions
* Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals
Participants will be asked
* To apply ACU-D1 on the lesions twice daily for 4 weeks
* 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.

Start Date01 Dec 2024

Sponsor / Collaborator

Emory University

[+1]

NCT03064438 / CompletedPhase 2

A RANDOMIZED, DOUBLE-BLIND, VEHICLE CONTROLLED, PROOF-OF CONCEPT STUDY OF THE SAFETY AND EFFICACY OF ACU-D1 OINTMENT IN SUBJECTS WITH ACNE ROSACEA

The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.

Start Date28 Nov 2017

Sponsor / Collaborator

Accuitis, Inc.

100 Clinical Results associated with ACU-D1

100 Translational Medicine associated with ACU-D1

100 Patents (Medical) associated with ACU-D1

Literatures (Medical) associated with ACU-D1

01 Jun 2021·Journal of drugs in dermatology : JDDQ4 · MEDICINE

Evaluation of a First-in-Class Proteasome Inhibitor in Patients With Moderate to Severe Rosacea.

Q4 · MEDICINE

Article

Author: Jackson, J Mark ; Coulon, Rick ; Arbiser, Jack L

BACKGROUNDNovel, 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.METHODSThis 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.CONCLUSIONThis 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.

100 Deals associated with ACU-D1

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rosacea	Phase 2	US	Accuitis, Inc.	28 Nov 2017
Anal intraepithelial neoplasia	Phase 1	US	Emory University	01 Dec 2024
HIV Infections	Phase 1	US	Emory University	01 Dec 2024
Human Papillomavirus Infection	Phase 1	US	Emory University	01 Dec 2024
Squamous Intraepithelial Lesions	Phase 1	US	Emory University	01 Dec 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03064438 (CTgov)	Phase 2	Rosacea	40	ACCU-D1 (ACU-D1 Ointment)	icjwenwcww(khclxjhxri) = siqwrdxhye qwojtkqgrl (yaczllpuui, boksoqxslu - kekmzlytxf) View more	-	23 Aug 2021
				Vehicle (ACU-D1 Ointment Vehicle)	icjwenwcww(khclxjhxri) = ttyrlzbwaq qwojtkqgrl (yaczllpuui, nnummfpsrk - aciwizvgkw) View more
NCT03064438 (Pubmed \| J Drugs Dermatol) Manual	Phase 2	Rosacea	40	ACU-D1	(kuzrwsbfjh) = ekdxdterjd fgminpowrt (jxhxhjciww ) View more	Positive	01 Jun 2021
				comparator	-

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