Apremilast in the Treatment of Moderate to Severe Acne

NCT01074502 | Terminated Phase 2 Results DMC

• 1 other identifier: CELG0001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Acne is a chronic inflammatory disease of the pilosebaceous unit that affects 80-90% of the population, especially teenagers, although adult acne is a significant problem for 3-6 % of adult men and 5-12% of adult women. Although acne is not a life-threatening disease, it produces significant psychological disturbances and permanent skin scars. A novel anti-inflammatory, not antibiotic drug may be an excellent alternative for the treatment of moderate to severe acne. Apremilast has been shown to inhibit the production of tumor necrosis factor (TNF)-alpha, IL-8 and neutrophil infiltration, all of which are elevated in inflammatory acne. Our intention is to study Apremilast in the treatment of moderate to severe acne.

Conditions

Acne

Keywords

acne

Outcome Measures

Primary Outcomes (4)

• Percentage of Patients With a Success Rate (Based on the Researcher's Global Assessment (RGA) Sum of Clear (0) or Almost Clear (1))

  RGA measures the severity of acne. The scale goes from 0-4. 0 will be better and 4 will be worse. Scores can only be whole numbers (0,1,2,3,4)ordinal.

  Baseline to 16 weeks

• Percentage of Patients With a Minimum 2-grade Improvement in the Researcher Global Assessment (RGA) From Baseline to Week 12.

  RGA measures the severity of acne. The scale goes from 0 (better)to 4 (worse). Score can only be whole numbers, ordinal.

  Baseline to 12 weeks

• Mean Percentage Change From Baseline in Individual Lesion Counts (Total, Inflammatory, Non-inflammatory) at Week 12

  Baseline to 12 weeks

• Percentage of Patients Achieving a Clear or Almost Clear PGA at 16 Weeks

  Baseline to 16 weeks

Secondary Outcomes (2)

• The Absolute Change in Lesion Counts (Total, Inflammatory, Non-inflammatory) From Baseline to Week 12

  Baseline to12 weeks

• Safety of Apremilast 20 Mgs BID for 12 Weeks Will be Assessed by Evaluating Adverse Events (AEs), Vital Signs, Laboratory Evaluations and Withdrawals From the Study

  Baseline to 16 weeks

Study Arms (1)

apremilast

EXPERIMENTAL

apremilast 20 mgs twice a day for 12 weeks

Drug: apremilast

Interventions

apremilast DRUG

apremilast 20 mgs orally twice a day for 12 weeks

apremilast

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must understand and voluntarily sign an informed consent form.
• Must be male or female and aged 18-45 years of age, inclusive, at time of consent and be in general good health.
• Must be able to adhere to the study visit schedule and other protocol requirements
• Moderate to severe acne ( a 3 or 4 score in the RGA) of the face at Baseline.
• Subjects with 17-100 non-inflammatory lesions (open and closed comedones) and with 25-150 inflammatory lesions (papules and pustules) and 0-15 nodules (no larger than 1 cm each) and no cystic lesions.
• Must meet the following laboratory criteria:
• Hemoglobin \> 12 g/dL
• White blood cell (WBC) count ≥ 3000 /mL (≥ 3.0 X 109/L) and ≤ 14,000/mL (\< 14 X 109/L)
• Platelets ≥ 100,000 /mL (≥ 100 X 109/L)
• Serum creatinine ≤ 1.5 mg/dL (or ≤ 133 μmol/L)
• Total bilirubin \< 2.0 mg/dL
• Aspartate transaminase (AST \[serum glutamic oxaloacetic transaminase, SGOT\]) and alanine transaminase (ALT \[serum glutamate pyruvic transaminase, SGPT\]) \< 1.5x upper limit of normal (ULN)
• Negative ANA
• Negative cANCA
• Negative antiphospholipid antibodies

You may not qualify if:

• Inability to provide voluntary consent
• Use of any topical acne treatment (salicylic acid, benzoyl peroxide, retinol, antibiotics) 2 weeks prior to Baseline.
• Use of topical astringents or antimicrobial soaps for one week prior to Baseline.
• Use of any topical retinoid, systemic antibiotic or topical or systemic corticosteroids in the face 4 weeks prior to Baseline.
• Use of a systemic retinoid, such as isotretinoin, 6 months prior to Baseline
• Any confluent nodule, cyst and/or sinus tract present.
• Any nodule larger than 10 mm.
• Subjects who are using medications that can exacerbate acne such as mega-doses of vitamin D, vitamin B2, B6, B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and Phenobarbital). Multivitamins, iron supplements and folate are acceptable, but should be used consistently throughout the study.
• Subjects who have had a facial procedure (chemical or laser peel, blue light treatment, microdermabrasion, etc) within 4 weeks before enrollment or during the study.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Subjects who abuse drugs or alcohol (drug screening not required).
• Pregnant, trying to become pregnant or breastfeeding.
• Use of estrogens, androgens or hormonal contraception or devices for less than 12 weeks prior to Baseline. Subjects are allowed to enroll as long as they do not expect to change dose, product, or discontinue use during the study.
• Systemic fungal infection
• History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Celgene: collaborator

Study Sites (1)

University Of North Carolina

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

apremilast

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Aida Lugo-Somolinos MD-PI
• Organization: UNC Chapel Hill

alugosom@med.unc.edu

919-843-9447

Study Officials

• Aida Lugo-Somolinos, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of dermatology

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 13, 2017
• Results First Posted: March 12, 2012

Record last verified: 2017-02

Locations

US (1)