Acne RosaceaPhase 1/2NCT00580723
Effects of PRK 124 Lotion in Acne Rosacea
A Phase 1/2 study testing PRK 124 in people with Acne Rosacea, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this open-label study is to determine the tolerance and efficacy of twice-daily application of PRK 124 (Pyratine-6)(0.125%) moisturizing lotion for improving the signs and symptoms of mild to moderate facial rosacea. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acne Rosacea
- What is being tested?
- PRK 124
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 21 years old
- be in reasonably good health as defined by the study doctor
- have routine laboratory tests to evaluate your blood cell count, and kidney and liver function
- for females of child-bearing age, not be pregnant or nursing and have a negative urine pregnancy test (except if surgically sterile or at least 1 year menopausal)
- for females, agree to use medically acceptable forms of birth control throughout the entire study (medically acceptable forms of birth control include oral contraceptive ["the pill"], implants such as Norplant®, injectable progesterone [Depo-provera®], diaphragm and spermicide or condoms and spermicide)
- must have mild to moderate acne rosacea
Show all 9Show fewer
- be willing to refrain from using non-approved lotions, moisturizer, cleansers or lotions on affected facial areas during the treatment period
- be capable of understanding and giving written, voluntary informed consent before study screening
- be willing to consent to facial photographs at baseline and each follow-up visit to monitor treatment with the test product.
Who cannot join
- have a history or evidence of any chronic or reoccurring skin disease or disorder (e.g., psoriasis, eczema, etc.) affecting the face
- have known or suspected hypersensitivity to study treatment or any of its ingredients
- have used systemic retinoids within 6 months prior to study entry (e.g., acitretin, isotretinoin)
- have received treatment with systemic corticosteroids (e.g. prednisone) or antibiotics within 1 month
- have used topical treatment to the face with retinoids (e.g. tretinoin, adapalene), or antibiotics or corticosteroids, within 2 weeks prior to study entry
- are unwilling to use a sunscreen with an SPF of 30 during the study
- have participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Irvine Dermatology Clinical Research Center
Irvine, California, 92697
About this study
Official title: Effects of PRK 124 (0.125%) Lotion in Acne Rosacea
The purpose of this open-label study is to determine the tolerance and efficacy of twice-daily application of PRK 124 (Pyratine-6)(0.125%) moisturizing lotion for improving the signs and symptoms of mild to moderate facial rosacea.
Read the detailed description
Cytokinins are plant growth factors that regulate plant growth and differentiation. PRK 124 (N-furfuryl-9-(2-tetrahydropyranyl) adenine)(Pyratine 6™) is a cytokinin that has been shown to have modulatory, anti-ROS (reactive oxygen species), and antisenescence effects on the growth of human skin cells.
Recent clinical studies showed that PRK 124 (0.1%) treatment in 40 subjects for 12 weeks improved the appearance of photodamaged facial skin by decreasing fine wrinkles, roughness and mottled hyperpigmentation. Treatment with PRK 124 lotion furthermore decreased skin transepidermal water loss and also increased skin moisture content. The topical PRK 124 lotion was well tolerated by the subjects with no significant increase in erythema or irritation. Treatment with PRK 124 was shown to decrease both acne and erythema observed at baseline.
Rosacea is a common, chronic dermatosis that is characterized by papules and pustules, persistent erythema and telangiectasia. The objective of this study is to compare the long-term efficacy and tolerance of PRK 124 (0.125%) moisturizing lotion applied twice daily for 48 weeks for improving the clinical signs and symptoms of inflammatory acne rosacea as well as cutaneous signs of skin photodamage.
Study Design:
Twenty four volunteers with mild-to-moderate facial rosacea will participate in this single center, open-label study designed to evaluate the subject=s tolerance and effectiveness of PRK 124 (0.125%) moisturizing lotion applied twice daily for 48 weeks, for improving the signs and symptoms of acne rosacea. Subjects will apply the test lotion twice daily, once in morning and again in the evening before bedtime. Subjects will be assessed at baseline and at 4, 8 and 12 weeks after treatment for improvement in the clinical signs and symptoms of acne rosacea and effect of treatments on transepidermal water loss (TEWL). In addition, the subject's tolerance will be assessed at each follow-up visit (weeks 4, 8, and 12). Facial photographs will be obtained at baseline and at 4, 8 and 12 weeks. Subjects will then be given the opportunity to continue treatment for 36 additional weeks. Subjects must have normal clinical laboratory tests, and if female, a negative urine pregnancy test at 12 weeks to continue the 36 weeks treatment. Clinical laboratory tests and urine pregnancy test will be repeated at week 48 or early study completion. Clinical assessments will be done at weeks 24, 36 and 48 during the last 36 weeks. Additional objective measures of skin moisture content and skin erythema using a chromameter will be done at week 12 and at follow-up visits (weeks 24, 36 and 48). Telephone follow-up will be done at weeks 16, 20, 28, 32 and 40 to assess subject tolerance and compliance.
Primary Study Variables:
The primary study variables are:
Observations by Investigator:
- Inflammatory lesion count
- Erythema and telangiectasia severity
- Global assessment of severity
- Overall improvement over baseline
- Photodamage (fine wrinkles, texture, mottled hyperpigmentation)
- Transepidermal water loss (TEWL)
- Skin moisture content
- Skin erythema as measured by a chromameter
Subject self assessment:
- Signs \& symptoms (burning/stinging, erythema/telangiectasia, papules/pustules)
- Overall improvement over baseline
- Photodamage (fine wrinkles, texture, mottled hyperpigmentation)
- Cosmetic acceptability
The local skin tolerance of the treatments will be assessed by the Investigator and by the subject.
- Conditions
- Acne Rosacea
- Being tested
- PRK 124
- Keywords
- acne, rosacea, acne rosacea, papulopustular rosacea, erythema, telangiectasia, flushing
- Medical subject headings
- Rosacea, Acne Vulgaris, Erythema, Telangiectasis, Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRK 124Other
Also called Pyratine-6, N-furfuryl-9-(2-tetrahydropyranyl)adenine
Topical PRK 124 (0.125%) moisturizing lotion applied twice daily to the face for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| PRK 124 | Experimental | Topical PRK 124 (Pyratine-6)(0.125%) moisturizing lotion applied twice daily to the face for 48 weeks. Subjects will wash their faces prior to application. The applications will occur in the mornings and one hour before bedtime. Receives: Other: PRK 124 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema Severity
Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean erythema severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.
Measured: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Inflammatory Lesion Count
Lesion counts were numerically summed for each patient at each encounter, and the average lesion count was calculated from all continuing 16 subjects at each visit, for a total of 8 visits. Percent improvement (reduction in lesion number) was assessed by comparing the average number of lesions at week 48 to the average number of lesions assessed at baseline.
Measured: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Telangiectasia Severity
Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean telangiectasia severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.
Measured: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Secondary outcomes (4)
Skin Tolerance
Measured: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Skin Photodamage
Measured: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Transepidermal Water Loss (TEWL)
Measured: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Cosmetic Acceptability
Measured: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne RosaceaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- SenetekPLC
- Responsible party
- Principal investigator, Christopher Zachary, University of California, Irvine
- Investigators
- Gerald D Weinstein, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580723
- Sponsor's protocol ID
- 2006-5307
- Other IDs
- Contract SPLC-41239
- Status last verified
- Dec 2013
- First submitted
- 21 Dec 2007
- Last updated
- 17 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Verbeke P, Siboska GE, Clark BF, Rattan SI. Kinetin inhibits protein oxidation and glycoxidation in vitro. Biochem Biophys Res Commun. 2000 Oct 5;276(3):1265-70. doi: 10.1006/bbrc.2000.3616.
PubMed 11027621Wu JJ, Weinstein GD, Kricorian GJ, Kormeili T, McCullough JL. Topical kinetin 0.1% lotion for improving the signs and symptoms of rosacea. Clin Exp Dermatol. 2007 Nov;32(6):693-5. doi: 10.1111/j.1365-2230.2007.02513.x. Epub 2007 Sep 14.
PubMed 17868391
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PRK 124 (0.125%) Lotion in Acne Rosacea
- ClinicalTrials.gov ID
- NCT00580723
- Acronym / sponsor ID
- 2006-5307
- Conditions
- Acne Rosacea
- Keywords
- acne, rosacea, acne rosacea, papulopustular rosacea, erythema, telangiectasia, flushing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- SenetekPLC
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 10 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open-label study is to determine the tolerance and efficacy of twice-daily application of PRK 124 (Pyratine-6)(0.125%) moisturizing lotion for improving the signs and symptoms of mild to moderate facial rosacea.
Detailed description
Cytokinins are plant growth factors that regulate plant growth and differentiation. PRK 124 (N-furfuryl-9-(2-tetrahydropyranyl) adenine)(Pyratine 6™) is a cytokinin that has been shown to have modulatory, anti-ROS (reactive oxygen species), and antisenescence effects on the growth of human skin cells.
Recent clinical studies showed that PRK 124 (0.1%) treatment in 40 subjects for 12 weeks improved the appearance of photodamaged facial skin by decreasing fine wrinkles, roughness and mottled hyperpigmentation. Treatment with PRK 124 lotion furthermore decreased skin transepidermal water loss and also increased skin moisture content. The topical PRK 124 lotion was well tolerated by the subjects with no significant increase in erythema or irritation. Treatment with PRK 124 was shown to decrease both acne and erythema observed at baseline.
Rosacea is a common, chronic dermatosis that is characterized by papules and pustules, persistent erythema and telangiectasia. The objective of this study is to compare the long-term efficacy and tolerance of PRK 124 (0.125%) moisturizing lotion applied twice daily for 48 weeks for improving the clinical signs and symptoms of inflammatory acne rosacea as well as cutaneous signs of skin photodamage.
Study Design:
Twenty four volunteers with mild-to-moderate facial rosacea will participate in this single center, open-label study designed to evaluate the subject=s tolerance and effectiveness of PRK 124 (0.125%) moisturizing lotion applied twice daily for 48 weeks, for improving the signs and symptoms of acne rosacea. Subjects will apply the test lotion twice daily, once in morning and again in the evening before bedtime. Subjects will be assessed at baseline and at 4, 8 and 12 weeks after treatment for improvement in the clinical signs and symptoms of acne rosacea and effect of treatments on transepidermal water loss (TEWL). In addition, the subject's tolerance will be assessed at each follow-up visit (weeks 4, 8, and 12). Facial photographs will be obtained at baseline and at 4, 8 and 12 weeks. Subjects will then be given the opportunity to continue treatment for 36 additional weeks. Subjects must have normal clinical laboratory tests, and if female, a negative urine pregnancy test at 12 weeks to continue the 36 weeks treatment. Clinical laboratory tests and urine pregnancy test will be repeated at week 48 or early study completion. Clinical assessments will be done at weeks 24, 36 and 48 during the last 36 weeks. Additional objective measures of skin moisture content and skin erythema using a chromameter will be done at week 12 and at follow-up visits (weeks 24, 36 and 48). Telephone follow-up will be done at weeks 16, 20, 28, 32 and 40 to assess subject tolerance and compliance.
Primary Study Variables:
The primary study variables are:
Observations by Investigator:
- Inflammatory lesion count
- Erythema and telangiectasia severity
- Global assessment of severity
- Overall improvement over baseline
- Photodamage (fine wrinkles, texture, mottled hyperpigmentation)
- Transepidermal water loss (TEWL)
- Skin moisture content
- Skin erythema as measured by a chromameter
Subject self assessment:
- Signs \& symptoms (burning/stinging, erythema/telangiectasia, papules/pustules)
- Overall improvement over baseline
- Photodamage (fine wrinkles, texture, mottled hyperpigmentation)
- Cosmetic acceptability
The local skin tolerance of the treatments will be assessed by the Investigator and by the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRK 124 | Experimental | Other: PRK 124Topical PRK 124 (Pyratine-6)(0.125%) moisturizing lotion applied twice daily to the face for 48 weeks. Subjects will wash their faces prior to application. The applications will occur in the mornings and one hour before bedtime. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be at least 21 years old
- be in reasonably good health as defined by the study doctor
- have routine laboratory tests to evaluate your blood cell count, and kidney and liver function
- for females of child-bearing age, not be pregnant or nursing and have a negative urine pregnancy test (except if surgically sterile or at least 1 year menopausal)
- for females, agree to use medically acceptable forms of birth control throughout the entire study (medically acceptable forms of birth control include oral contraceptive ["the pill"], implants such as Norplant®, injectable progesterone [Depo-provera®], diaphragm and spermicide or condoms and spermicide)
Key exclusion criteria (7 listed)
- have a history or evidence of any chronic or reoccurring skin disease or disorder (e.g., psoriasis, eczema, etc.) affecting the face
- have known or suspected hypersensitivity to study treatment or any of its ingredients
- have used systemic retinoids within 6 months prior to study entry (e.g., acitretin, isotretinoin)
- have received treatment with systemic corticosteroids (e.g. prednisone) or antibiotics within 1 month
- have used topical treatment to the face with retinoids (e.g. tretinoin, adapalene), or antibiotics or corticosteroids, within 2 weeks prior to study entry
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 |
|---|---|---|
| PRK 124Also: Pyratine-6, N-furfuryl-9-(2-tetrahydropyranyl)adenineTopical PRK 124 (0.125%) moisturizing lotion applied twice daily to the face for 48 weeks | Other | PRK 124 |
Primary outcome
Erythema Severity
Time frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean erythema severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.
Inflammatory Lesion Count
Time frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Lesion counts were numerically summed for each patient at each encounter, and the average lesion count was calculated from all continuing 16 subjects at each visit, for a total of 8 visits. Percent improvement (reduction in lesion number) was assessed by comparing the average number of lesions at week 48 to the average number of lesions assessed at baseline.
Telangiectasia Severity
Time frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean telangiectasia severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.
4 secondary outcomes
Skin Tolerance
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Skin Photodamage
Time frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Transepidermal Water Loss (TEWL)
Time frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Cosmetic Acceptability
Time frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11027621Verbeke P, Siboska GE, Clark BF, Rattan SI. Kinetin inhibits protein oxidation and glycoxidation in vitro. Biochem Biophys Res Commun. 2000 Oct 5;276(3):1265-70. doi: 10.1006/bbrc.2000.3616.
- Background: PubMed 17868391Wu JJ, Weinstein GD, Kricorian GJ, Kormeili T, McCullough JL. Topical kinetin 0.1% lotion for improving the signs and symptoms of rosacea. Clin Exp Dermatol. 2007 Nov;32(6):693-5. doi: 10.1111/j.1365-2230.2007.02513.x. Epub 2007 Sep 14.
- UC Irvine Department of DermatologyLink provided by the sponsor.
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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.
Gerald D Weinstein, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRK 124 in people with Acne Rosacea, run by University of California, Irvine 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 17 Jan 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 10 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Erythema Severity (time frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00580723, which also lists 2 linked publications.
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 17 Jan 2014.