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

• ClinicalTrials.gov Identifier: NCT02704507
• Recruitment Status: Unknown
• First Posted: March 10, 2016
• Last Update Posted: March 10, 2016
• Sponsor: Carilion Clinic
• Information provided by (Responsible Party): Michael Kolodney, Carilion Clinic

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Carilion Clinic

Investigators

• Principal Investigator: Michael Kolodney, MD, PhD; Carilion Clinic

More Information

• Responsible Party: Michael Kolodney, Section Chief Dermatology, Carilion Clinic Dermatology, Carilion Clinic
• ClinicalTrials.gov Identifier: NCT02704507
• Other Study ID Numbers: 1771
• First Posted: March 10, 2016
• 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:

Triamcinolone; Tretinoin; Emollients; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents; Keratolytic Agents; Dermatologic Agents