Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

NCT02559934 | Completed Phase 1

• 1 other identifier: GESRTAKD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing 2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous dermal treatment area.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (10)

• AUC0-τ,ss;

  AUC0-τ,ss was determined by the area under the plasma concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule

  sixteen consecutive weeks.

• AUMC0-τ,ss

  AUMC0-τ,ss was determined by the area under the plasma (first) moment concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule according to the following equation: AUMC0-τ,ss = Σ\[(tn - tn-1)(Cn-1tn-1 + Cntn) /2\]

  sixteen consecutive weeks.

• Cmax,ss;

  Cmax,ss was determined by the the highest observed plasma concentration at steady state (the last dosing interval)

  sixteen consecutive weeks.

• Cmin,ss;

  Cmin,ss was determined by the minimum observed plasma concentration at steady state

  sixteen consecutive weeks.

• Cave,ss

  Cave,ss was determined by the average plasma concentration at steady state (the last dosing interval) according to the following equation: Cave,ss = AUCss / dosing interval

  sixteen consecutive weeks.

• Fluctuation

  Fluctuation was determined by the Fluctuation index of concentration at steady state

  sixteen consecutive weeks.

• Tmax,ss;

  Tmax,ss was determined by the time to reach highest observed plasma concentration at steady state (the last dosing interval)

  sixteen consecutive weeks.

• kel

  kel was determined by the plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration

  sixteen consecutive weeks.

• T½;

  T½ was determined by the plasma half-life estimated by (0.693/kel)

  sixteen consecutive weeks.

• MRTss

  MRTss was determined by the mean residence time determined by AUMC0-τ,ss / AUC0-τ,ss

  sixteen consecutive weeks.

Secondary Outcomes (1)

• Adverse events will be recorded to evaluate the safety outcome.

  sixteen consecutive weeks.

Study Arms (1)

SR-T100 gel

EXPERIMENTAL

A single dose of 0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 25 cm2 skin area covered by an occlusive dressing at least 20 hours a day and will be given once daily for sixteen consecutive weeks.

Drug: SR-T100 Gel

Interventions

SR-T100 Gel DRUG

0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract)

Also known as: Solamargine

SR-T100 gel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female is 20 years of age or above.
• Patient has AK lesions located within a 25 cm2 contiguous or non-contiguous treatment area.
• Patient has at least one clinical confirmed AK lesion within the selected treatment area before.

You may not qualify if:

• Patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon or cytotoxic drugs.
• Patient had treated with topical 5-FU, diclofenac gel, imiquimod, ingenol mebutate, corticosteroids, retinoids or masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
• Patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy or surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
• Patient had received any of the following treatments on the treatment area in the 6 months before study treatment initiation: psoralen plus Ultraviolet A therapy, Ultraviolet B therapy, laser abrasion, dermabrasion, chemical peel.
• Patient had used any topical preparations, such as sunscreens, moisturizers, body oils, or alpha or beta hydroxyl acids, in the treatment area within 24 hours before and during the study course.
• Patient is known to be hypersensitive to the study medication.
• Female who is pregnant, breast-feeding or considering becoming pregnant while during the study.
• Donation of 500 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing.
• Patient had used of any investigational drug within the past 30 days before enrollment.
• Patient has any dermatological disease and/or condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area (5 cm distances from treatment area).

Sponsors & Collaborators

• G&E Herbal Biotechnology Co., LTD: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

beta-solamarine

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kou-Wha Kuo, PhD

  G&E Herbal Biotechnology Co., LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: September 25, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

TW (1)