Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01045551
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2010-01-07
Brief Title:
Open Label Pilot Study of Apremilast in Treatment of Rosacea
Sponsor:
Julian M Mackay-Wiggan
Organization:
Columbia University
Study Overview
Official Title:
An Open Label Pilot Study to Determine the Efficacy of Apremilast in the Treatment of Rosacea in Patients With Both Erythematotelangiectatic Rosacea and Papulopustular Rosacea
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rosacea is a chronic skin disorder with the signs and symptoms of facial flushing persistent redness small visible spider-like veins papules inflamed red bumps under the skin and pustules Rosacea is also a a recurring skin disorder In addition to causing uncomfortable and embarrassing physical symptoms such as flushing burning and itching rosacea can also contribute to lower self-esteem which can have a significant psychosocial impact on quality of life Rosacea flares can be triggered by every day factors such as sun exposure heat hot or caffeinated drinks alcoholic beverages spices and stress
Many of the currently available treatments for rosacea are only partially effective and some patients do not respond to them or are unable to tolerate the side effects
This is a single-center open label trial of Apremilast in ten 10 subjects with moderate to severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12 weeks Following the screening period and baseline visit study subjects will return at weeks 1 2 4 6 8 10 and 12 There is a follow up study visit at week 16
Recent research has shown an increase of specific proinflammatory cytokines in the biopsies of inflammatory lesions from rosacea and acne patients The cytokines then trigger a chain of chemical responses in the body that likely result in the development of the papules an pustules that are seen in rosacea and acne patients Apremilast is an oral agent that modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with potential therapeutic benefit for treating inflammatory autoimmune disorders
The investigators therefore propose a pilot study to evaluate the potential for Apremilast to improve the signs and symptoms of moderate to severe inflammatory rosacea
Many of the currently available treatments for rosacea are only partially effective and some patients do not respond to them or are unable to tolerate the side effects
This is a single-center open label trial of Apremilast in ten 10 subjects with moderate to severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12 weeks Following the screening period and baseline visit study subjects will return at weeks 1 2 4 6 8 10 and 12 There is a follow up study visit at week 16
Recent research has shown an increase of specific proinflammatory cytokines in the biopsies of inflammatory lesions from rosacea and acne patients The cytokines then trigger a chain of chemical responses in the body that likely result in the development of the papules an pustules that are seen in rosacea and acne patients Apremilast is an oral agent that modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with potential therapeutic benefit for treating inflammatory autoimmune disorders
The investigators therefore propose a pilot study to evaluate the potential for Apremilast to improve the signs and symptoms of moderate to severe inflammatory rosacea
Detailed Description:
This is a single-center open label pilot study of Apremilast in ten subjects with both erythematotelangiectatic rosacea and papulopustular rosacea in which subjects will be treated with Apremilast 20mg twice per day for 12 weeks There is a total of 10 visits over a period of 16 weeks
Adult male and female subjects 18 years of age or older will participate in the study after the objectives methods and potential hazards of the study have been fully explained and after they have signed the informed consent form Subjects must have a diagnosis or findings consistent with erythematotelangiectatic and papulopustular rosacea Subjects must have at least 10 papulopustular lesions with underlying erythematelangiectasias visible to the unassisted naked eye
Subjects will take Apremilast capsules 20mg twice per day for 12 weeks If at anytime during the study a subject encounters overt study medication related adverse effects dose reduction will be allowed following discussions between the subject and the investigator Dose reductions to 20mg once per day will be allowed for subjects who experience intolerable adverse effects from the study medication If the subject cannot tolerate 20mg per day heshe will be terminated from the study
Adult male and female subjects 18 years of age or older will participate in the study after the objectives methods and potential hazards of the study have been fully explained and after they have signed the informed consent form Subjects must have a diagnosis or findings consistent with erythematotelangiectatic and papulopustular rosacea Subjects must have at least 10 papulopustular lesions with underlying erythematelangiectasias visible to the unassisted naked eye
Subjects will take Apremilast capsules 20mg twice per day for 12 weeks If at anytime during the study a subject encounters overt study medication related adverse effects dose reduction will be allowed following discussions between the subject and the investigator Dose reductions to 20mg once per day will be allowed for subjects who experience intolerable adverse effects from the study medication If the subject cannot tolerate 20mg per day heshe will be terminated from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AP-ROS-PI 0033 | OTHER | Celgene | None |