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

Acne Clinical Trial

Official title:

Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02704507
• Other study ID #: 1771
• Status: Active, not recruiting
• Phase: N/A
• First received: February 13, 2016
• Last updated: March 5, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Triamcinolone
topical application nightly to half the face for 4 weeks
• Tretinoin
topical application nightly for 8 weeks
• Emollient
topical application nightly to half the face for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subject-assessed itching and burning/stinging assessed by a 0-3 score over 8 weeks	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.	baseline, weeks 1,2, 4, and 8	No
Primary	Change in physician-assessed erythema scores assessed by a 0-4 scale over 8 weeks.	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.	baseline, weeks 1,2, 4, and 8	No
Primary	Change in physician-assessed dryness scores assessed by a 0-4 scale over 8 weeks.	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.	baseline, weeks 1,2, 4, and 8	No
Primary	Change in physician-assessed peeling scores assessed by a 0-4 scale over 8 weeks.	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.	baseline, weeks 1,2, 4, and 8	No
Secondary	Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks	Physicians will count the inflammatory and non-inflammatory lesions on each side of the face over 8 weeks.	baseline, weeks 1,2, 4, and 8	No
Secondary	Change in physician-assessed global acne scores over 8 weeks.	Physicians will grade each side of the subject's face on the "Global Acne Score" 0-5 over 8 weeks.	baseline, weeks 1,2, 4, and 8	No