Proof of Concept Study to Investigate the Recurrence of Acne Post Isotretinoin

NCT00939133 | Completed Phase 4

• 1 other identifier: C2009-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for non-inflammatory papules and comedones to recur. However, there has been no formal study to look at the prevention of recurrence of these acne lesions post isotretinoin in a long term basis. This may enhance the therapeutic options for post isotretinoin patients in order to prevent recurrence of their disease. Hypothesis Tretinoin microsphere 0.04% will prevent recurrence of acne lesions.

Conditions

Acne

Keywords

acne; tretinoin; isotretinoin; recurrence; Retin A micro

Outcome Measures

Primary Outcomes (1)

• Primary objectives-to assess the efficacy of Retin A micro 0.04% on the recurrence rate of acne post isotretinoin use compared to vehicle.

  Six Months

Secondary Outcomes (3)

• The percent change in lesion counts from baseline to week 16 and 24.

  Six Months

• Proportion of subjects who have a Subject's Global

  Assessment score of 0 or 1 at week 16 and 24

• Proportion of subjects who have an ISGA score of 0 or 1 at week 16 and 24.

  At week 16 and 24

Study Arms (2)

Tretinoin microsphere 0.04% gel

ACTIVE COMPARATOR

Drug: tretinoin microsphere 0.04% gel

Vehicle gel

PLACEBO COMPARATOR

Drug: vehicle gel

Interventions

tretinoin microsphere 0.04% gel DRUG

Applied daily to entire face for six months

Also known as: Retin A micro 0.04%

Tretinoin microsphere 0.04% gel

vehicle gel DRUG

Placebo

Vehicle gel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must fulfill all of the following criteria to be eligible for study admission:
• Males aged between 18 and 45 years old who have successfully completed a treatment of acne with oral isotretinoin (Min 4 months/Maximum 6 months with an average of 5 months and a total of 120-150mg/kg/course).
• Who can attend scheduled study follow-up visits at the outpatient dermatology clinic.
• Agree to informed consent for participation in a study.
• Agree to comply with the treatment and follow up procedures.

You may not qualify if:

• Patients who receive isotretinoin for condition other than acne vulgaris.
• Patients who have been off isotretinoin for less than 30 days or more than 90 days at the time of enrollment of the study.
• Patients who have used prescription topical acne treatment (tretinoin, benzoyl peroxide, topical antibiotics or any combination products) between the end of therapy of isotretinoin within 2 weeks of study enrollment or oral antibiotics of any type between the end of therapy of isotretinoin within 4 weeks of study enrollment and throughout the study.
• Patients who have been previously diagnosed with an endocrinological disorder likely to cause acne such as genital/adrenal hyperplasia, adrenal tumors or any other hypo androgenetic state.
• Patients who are using any of the systemic medications likely to cause or abate acne such as oral Dilantin or any other epileptic, Finasteride, Spironolactone or Flutamine, testosterone or dietary body-building protein powders.
• Have any nodulo-cystic lesions at baseline.
• Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
• Are currently using any medication that in the opinion of the investigator may affect the action or evaluation of the study product or place the subject at undue risk.
• Used abradants, facials, peels containing glycolic or other acids; masks, washes, or soaps containing BPO, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers; moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids within the past 2 weeks.
• Plan to use medications that are reported to exacerbate acne (e.g., mega-doses of certain vitamins, such as vitamin D \[\> 2000 IU per day\] and vitamin B12 \[\> 1 mg/day\], haloperidol, halogens \[e.g., iodide and bromide\], lithium, hydantoin, and phenobarbital), because these may impact efficacy assessments. Subjects who plan to use multivitamins, iron supplements and folate are acceptable.
• Had a facial procedure (such as chemical or laser peel, microdermabrasion, blue light treatment, etc) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or if it is planned to be performed during the conduct of the study.
• Have a known hypersensitivity or have had previous allergic reaction to any of the active components or excipients of the study product.
• Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.
• Are currently abusing drugs or alcohol (drug screening not required).
• Have a significant medical history of being immunocompromised.

Sponsors & Collaborators

• Dermatrials Research: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Dermatrials Research

Hamilton, Ontario, L8N 1V6, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris; Recurrence

Interventions

Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ronald Vender, MD FRCPC

  Dermatrials Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FRCPC

Study Record Dates

• First Submitted: July 11, 2009
• First Posted: July 14, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

CA (1)