AcneNCT02704507
Addition of a Topical Steroid to a Topical Retinoid in Acne Patients
A study testing Triamcinolone, Tretinoin and Emollient in people with Acne, run by Carilion Clinic.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Triamcinolone, Tretinoin and Emollient
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study
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.
Read the 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.
- Conditions
- Acne
- Being tested
- Triamcinolone, Tretinoin, Emollient
- Keywords
- tretinoin, topical steroid, irritation, retinoid induced irritation
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
topical application nightly to half the face for 4 weeks
TretinoinDrug
topical application nightly for 8 weeks
EmollientDrug
topical application nightly to half the face for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Topical steroid | Experimental | 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. Receives: Drug: Triamcinolone; Drug: Tretinoin |
| Topical emollient | Placebo comparator | Topical retinoid plus topical emollient applied daily to the opposite half of the face for 4 weeks, followed by 4 weeks of topical tretinoin. Receives: Drug: Tretinoin; Drug: Emollient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, weeks 1,2, 4, and 8
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.
Measured: baseline, weeks 1,2, 4, and 8
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.
Measured: baseline, weeks 1,2, 4, and 8
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.
Measured: baseline, weeks 1,2, 4, and 8
Secondary outcomes (2)
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.
Measured: baseline, weeks 1,2, 4, and 8
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.
Measured: baseline, weeks 1,2, 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kolodney, Carilion Clinic
- Investigators
- Michael Kolodney, MD, PhD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704507
- Sponsor's protocol ID
- 1771
- Status last verified
- Mar 2016
- First submitted
- 13 Feb 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of a Topical Steroid to a Topical Retinoid: a Randomized, Split-face, Placebo-controlled, Double-blind, Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT02704507
- Acronym / sponsor ID
- 1771
- Conditions
- Acne
- Keywords
- tretinoin, topical steroid, irritation, retinoid induced irritation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical steroid | Experimental | Drug: Triamcinolone, Drug: TretinoinTopical 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. |
| Topical emollient | Placebo comparator | Drug: Tretinoin, Drug: EmollientTopical retinoid plus topical emollient applied daily to the opposite half of the face for 4 weeks, followed by 4 weeks of topical tretinoin. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolonetopical application nightly to half the face for 4 weeks | Drug | Topical steroid |
| Tretinointopical application nightly for 8 weeks | Drug | Topical emollient, Topical steroid |
| Emollienttopical application nightly to half the face for 4 weeks | Drug | Topical emollient |
Primary outcome
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.
2 secondary outcomes
Change in physician-assessed inflammatory and non-inflammatory lesion counts over 8 weeks
Time frame: baseline, weeks 1,2, 4, and 8
Change in physician-assessed global acne scores over 8 weeks.
Time frame: baseline, weeks 1,2, 4, and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kolodney, MD, PhD principal investigator
Carilion Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone, Tretinoin and Emollient in people with Acne, run by Carilion Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.