Effects of PRK 124 Lotion in Acne Rosacea

NCT ID: NCT00580723

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-02-28

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRK 124

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.

Group Type: EXPERIMENTAL

PRK 124

Intervention Type: OTHER

Topical PRK 124 (0.125%) moisturizing lotion applied twice daily to the face for 48 weeks

Interventions

PRK 124

Topical PRK 124 (0.125%) moisturizing lotion applied twice daily to the face for 48 weeks

Intervention Type: OTHER

Other Intervention Names

Pyratine-6; N-furfuryl-9-(2-tetrahydropyranyl)adenine

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SenetekPLC

UNKNOWN

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Christopher Zachary

MBBS, FRCP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald D Weinstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

UC Irvine Dermatology Clinical Research Center

Irvine, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11027621 (View on PubMed)

Wu 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.

Reference Type: BACKGROUND

PMID: 17868391 (View on PubMed)

Related Links

http://www.dermatology.uci.edu

UC Irvine Department of Dermatology

Other Identifiers

Contract SPLC-41239

Identifier Type: OTHER

Identifier Source: secondary_id

2006-5307

Identifier Type: -

Identifier Source: org_study_id