Effects of PRK 124 Lotion in Acne Rosacea

NCT00580723 | Completed Phase 1 Results DMC

• 2 other identifiers: 2006-5307Contract SPLC-41239
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Rosacea

Keywords

acne; rosacea; acne rosacea; papulopustular rosacea; erythema; telangiectasia; flushing

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Secondary Outcomes (4)

• Skin Tolerance

  Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

• Skin Photodamage

  Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

• Transepidermal Water Loss (TEWL)

  Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

• Cosmetic Acceptability

  Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Study Arms (1)

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.

Other: PRK 124

Interventions

PRK 124 OTHER

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

Also known as: Pyratine-6, N-furfuryl-9-(2-tetrahydropyranyl)adenine

PRK 124

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• SenetekPLC: collaborator

Study Sites (1)

UC Irvine Dermatology Clinical Research Center

Irvine, California, 92697, United States

Location

Related Publications (2)

• 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.

  PMID: 11027621 BACKGROUND

• 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.

  PMID: 17868391 BACKGROUND

Related Links

• UC Irvine Department of Dermatology

MeSH Terms

Conditions

Rosacea; Acne Vulgaris; Erythema; Telangiectasis; Flushing

Interventions

pyratine 6

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Brian Swasdibutra, Clinical Research Coordinator
• Organization: University of California, Irvine

bswasdib@uci.edu

9498247103

Study Officials

• Gerald D Weinstein, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, FRCP

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 17, 2014
• Results First Posted: December 10, 2013

Record last verified: 2013-12

Locations

US (1)