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Addition of a Topical Steroid to a Topical Retinoid in Acne Patients

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ClinicalTrials.gov Identifier: NCT02704507
Recruitment Status : Unknown
Verified March 2016 by Michael Kolodney, Carilion Clinic.
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Kolodney, Carilion Clinic

Tracking Information
First Submitted Date  ICMJE February 13, 2016
First Posted Date  ICMJE March 10, 2016
Last Update Posted Date March 10, 2016
Study Start Date  ICMJE June 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2016)
  • Change in subject-assessed itching and burning/stinging assessed by a 0-3 score over 8 weeks [ Time Frame: baseline, weeks 1,2, 4, and 8 ]
    Subject will given a questionnaire to assess itching and burning/stinging on each side of the face on a 0-3 scale: (0) None- Normal, no discomfort; (1) Slight- A noticeable discomfort that causes intermittent awareness; (2) Moderate- A noticeable discomfort that causes intermittent awareness and interferes occasionally with normal daily activities; (3) Strong- A definite continuous discomfort that interferes with normal daily activities.
  • Change in physician-assessed erythema scores assessed by a 0-4 scale over 8 weeks. [ Time Frame: baseline, weeks 1,2, 4, and 8 ]
    Physicians will assess each side of subjects' face for erythema: (0) absent: no redness; (1) slight: Faint red or pink coloration, barely perceptible; (2) mild: light red or pink coloration; (3) moderate: medium red coloration; (4) severe: beet red coloration.
  • Change in physician-assessed dryness scores assessed by a 0-4 scale over 8 weeks. [ Time Frame: baseline, weeks 1,2, 4, and 8 ]
    Physicians will assess each side of subjects' face for dryness: (0) absent: none; (1) slight: barely perceptible dryness with no flakes or fissure formation; (2) mild: easily perceptible dryness with no flakes or fissure formation; (3) moderate: easily noted dryness and flakes but no fissure formation; (4) severe:easily noted dryness with flakes and fissure formation.
  • Change in physician-assessed peeling scores assessed by a 0-4 scale over 8 weeks. [ Time Frame: baseline, weeks 1,2, 4, and 8 ]
    Physicians will assess each side of subjects' face for peeling: (0) absent: no peeling; (1) slight:mild localized peeling; (2) mild: mild and diffuse peeling; (3) moderate: moderate and diffuse peeling; (4) severe:moderate to prominent, dense peeling.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2016)
  • Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks [ Time Frame: baseline, weeks 1,2, 4, and 8 ]
    Physicians will count the inflammatory and non-inflammatory lesions on each side of the face over 8 weeks.
  • Change in physician-assessed global acne scores over 8 weeks. [ Time Frame: baseline, weeks 1,2, 4, and 8 ]
    Physicians will grade each side of the subject's face on the "Global Acne Score" 0-5 over 8 weeks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addition of a Topical Steroid to a Topical Retinoid in Acne Patients
Official Title  ICMJE Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study
Brief Summary A randomized, split-face, placebo-controlled, double-blind, single-center clinical trial comparing topical retinoid on half the face and retinoid plus topical steroid on the other half.
Detailed Description A randomized, split-face, placebo-controlled, double-blind, single-center clinical trial wherein 20 patients received daily 0.05% tretinoin with one half of the face receiving triamcinolone 0.025% and the other half an inert emollient for 4 weeks. Subjects continued applying tretinoin 0.05% daily to the bilateral face without triamcinolone or emollient for an additional 4 weeks. Investigator's Global Assessment, lesion counts, and study subject's self-assessments of burning/stinging, itching, erythema, and dryness/scaling will be collected at 1, 2, 4, and 8 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • Drug: Triamcinolone
    topical application nightly to half the face for 4 weeks
  • Drug: Tretinoin
    topical application nightly for 8 weeks
  • Drug: Emollient
    topical application nightly to half the face for 4 weeks
Study Arms  ICMJE
  • Experimental: Topical steroid
    Topical retinoid plus topical steroid applied daily to half of the face for 4 weeks, followed by 4 weeks of topical tretinoin. Patients will be randomized to which side receives the topical steroid.
    Interventions:
    • Drug: Triamcinolone
    • Drug: Tretinoin
  • Placebo Comparator: Topical emollient
    Topical retinoid plus topical emollient applied daily to the opposite half of the face for 4 weeks, followed by 4 weeks of topical tretinoin.
    Interventions:
    • Drug: Tretinoin
    • Drug: Emollient
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 5, 2016)
20
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fitzpatrick skin types I, II, or III
  • Will and ability to discontinue use of topical medicines on the face for study duration
  • Capability to understand and provide informed consent

Exclusion Criteria:

  • Use of oral retinoids within previous 6 months
  • Use of corticosteroids on the face or systemic corticosteroids within previous 4 weeks
  • Any additional facial skin condition (i.e., rosacea, seborrheic dermatitis, etc.)
  • Female participants who are pregnant, nursing, or planning pregnancy while participating in the study
  • Hypersensitivity to ingredients in study formulations
  • Existence of an underlying condition that an investigator feels would hinder a participant's ability to complete the study or appropriately follow directions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02704507
Other Study ID Numbers  ICMJE 1771
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Kolodney, Carilion Clinic
Study Sponsor  ICMJE Carilion Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Kolodney, MD, PhD Carilion Clinic
PRS Account Carilion Clinic
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP