RosaceaPhase 2NCT06312813
Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
A Phase 2 study testing Imipramine and Amitriptyline in people with Rosacea, run by Wright State University at 1 site in United States.
Trial summary
Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Imipramine and Amitriptyline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2024to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type I - IIII
- Self-identified rosacea or no history of flushing/blushing for controls
- Able to provide medical history and list of medications -- control subjects will not be allowed to take medications that are known to be photosensitizers.
Who cannot join
- Using imipramine, amitriptyline or any other tricyclic antidepressant (oral or topical)
- Using topical anti-inflammatory (within 1 week) or systemic agents (e.g. prednisone)
- Large tattoos in the designated testing areas
- Tanning bed use within last 3 months
- Photodynamic Therapy or UCB treatments in past 3 months
- Female Subjects: pregnant or nursing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wright State Physicians
Fairborn, Ohio, 45324
Pharmacology Translational Unit, (937)-245-7500, pturesearch@wrightstatephysicians.org
Travers
About this study
Official title: Pilot Studies Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipramineDrug
4% imipramine
AmitriptylineDrug
4% amitriptyline
VehicleDrug
0.1ml propylene glycol
| Study group | Role | What they receive |
|---|---|---|
| Imipramine and Vehicle | Experimental | 4% imipramine and vehicle are applied on a 2x2cm2 area of the subject's cheek. The imipramine is applied on one side of the subject's face (cheek) and vehicle is applied on the other side. Receives: Drug: Imipramine; Drug: Vehicle |
| Amitriptyline and Vehicle | Experimental | 4% amitriptyline and vehicle are applied on a 2x2cm2 area of the subject's cheek. The amitriptyline is applied on side of the subject's face (cheek) and vehicle is applied on the other side. Receives: Drug: Amitriptyline; Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Measured: 10 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Measured: 60 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Measured: 120 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Measured: 24 hours post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Measured: 10 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Measured: 60 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Measured: 120 minutes post-treatment
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Measured: 24 hours post-treatment
Secondary outcomes (8)
Tolerability of 4% imipramine on facial skin
The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch]
Measured: 10 minutes post-treatment
Tolerability of 4% imipramine on facial skin
The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch]
Measured: 60 minutes post-treatment
Tolerability of 4% imipramine on facial skin
The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch]
Measured: 120 minutes post-treatment
Tolerability of 4% imipramine on facial skin
The tolerability of 4% imipramine on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch]
Measured: 24 hours post-treatment
Tolerability of 4% amitriptyline on facial skin
The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch]
Measured: 10 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin
The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch]
Measured: 60 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin
The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch]
Measured: 120 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin
The tolerability of 4% amitriptyline on facial skin at baseline/Day 1 compared to Day 2 is measured by the Visual Analog Scale for pain and itch. [0= no skin pain/itch; 10 = severe skin pain/itch]
Measured: 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start27 Feb 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312813
- Sponsor's protocol ID
- 2023-296
- Status last verified
- Feb 2026
- First submitted
- 8 Mar 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
- ClinicalTrials.gov ID
- NCT06312813
- Acronym / sponsor ID
- 2023-296
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Mar 2024 (actual)
- 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.
Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imipramine and Vehicle | Experimental | Drug: Imipramine, Drug: Vehicle4% imipramine and vehicle are applied on a 2x2cm2 area of the subject's cheek. The imipramine is applied on one side of the subject's face (cheek) and vehicle is applied on the other side. |
| Amitriptyline and Vehicle | Experimental | Drug: Amitriptyline, Drug: Vehicle4% amitriptyline and vehicle are applied on a 2x2cm2 area of the subject's cheek. The amitriptyline is applied on side of the subject's face (cheek) and vehicle is applied on the other side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fitzpatrick Skin Type I - IIII
- Self-identified rosacea or no history of flushing/blushing for controls
- Able to provide medical history and list of medications -- control subjects will not be allowed to take medications that are known to be photosensitizers.
Key exclusion criteria (6 listed)
- Using imipramine, amitriptyline or any other tricyclic antidepressant (oral or topical)
- Using topical anti-inflammatory (within 1 week) or systemic agents (e.g. prednisone)
- Large tattoos in the designated testing areas
- Tanning bed use within last 3 months
- Photodynamic Therapy or UCB treatments in past 3 months
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 |
|---|---|---|
| Imipramine4% imipramine | Drug | Imipramine and Vehicle |
| Amitriptyline4% amitriptyline | Drug | Amitriptyline and Vehicle |
| Vehicle0.1ml propylene glycol | Drug | Amitriptyline and Vehicle, Imipramine and Vehicle |
Primary outcome
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Time frame: 10 minutes post-treatment
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Time frame: 60 minutes post-treatment
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Time frame: 120 minutes post-treatment
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
Time frame: 24 hours post-treatment
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Time frame: 10 minutes post-treatment
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Time frame: 60 minutes post-treatment
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Time frame: 120 minutes post-treatment
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
Time frame: 24 hours post-treatment
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
8 secondary outcomes
Tolerability of 4% imipramine on facial skin
Time frame: 10 minutes post-treatment
Tolerability of 4% imipramine on facial skin
Time frame: 60 minutes post-treatment
Tolerability of 4% imipramine on facial skin
Time frame: 120 minutes post-treatment
Tolerability of 4% imipramine on facial skin
Time frame: 24 hours post-treatment
Tolerability of 4% amitriptyline on facial skin
Time frame: 10 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin
Time frame: 60 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin
Time frame: 120 minutes post-treatment
Tolerability of 4% amitriptyline on facial skin
Time frame: 24 hours post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imipramine and Amitriptyline in people with Rosacea, run by Wright State University at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manager Clinical Research Operations ((937)-245-7500, pturesearch@wrightstatephysicians.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in redness of Ultraviolet B induced erythema with 4% imipramine (time frame: 10 minutes post-treatment). The study lists 8 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 18 Feb 2026.