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Trial record 42 of 144 for:    acne AND erythema

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

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.

Condition or disease Intervention/treatment Phase
Acne Drug: Triamcinolone Drug: Tretinoin Drug: Emollient Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tretinoin

Arm Intervention/treatment
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.
Drug: Triamcinolone
topical application nightly to half the face for 4 weeks

Drug: Tretinoin
topical application nightly for 8 weeks

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.
Drug: Tretinoin
topical application nightly for 8 weeks

Drug: Emollient
topical application nightly to half the face for 4 weeks




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704507


Sponsors and Collaborators
Carilion Clinic
Investigators
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Principal Investigator: Michael Kolodney, MD, PhD Carilion Clinic

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Responsible Party: Michael Kolodney, Section Chief Dermatology, Carilion Clinic Dermatology, Carilion Clinic
ClinicalTrials.gov Identifier: NCT02704507     History of Changes
Other Study ID Numbers: 1771
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016

Keywords provided by Michael Kolodney, Carilion Clinic:
tretinoin
topical steroid
irritation
retinoid induced irritation

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Tretinoin
Emollients
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents