Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03502434
Other study ID # SM04755-TOP-02
Secondary ID
Status Completed
Phase Phase 1
First received March 28, 2018
Last updated April 10, 2018
Start date September 11, 2017
Est. completion date November 17, 2017

Study information

Verified date April 2018
Source Samumed LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center, randomized, controlled, within subject comparison, single dose study to determine the sensitization potential of SM04755 solution on normal skin under semi-occlusive patch conditions.


Description:

This Phase 1, Repeat Insult Patch Test (RIPT) study is a single-center study of topical SM04755 solution repetitively applied to skin of healthy volunteers. This study will assess the potential of the Test Materials to induce contact sensitization as measured by treatment emergent adverse events (TEAEs), Reaction Grade and Investigator assessment of irritation and sensitization.


Recruitment information / eligibility

Status Completed
Enrollment 223
Est. completion date November 17, 2017
Est. primary completion date November 17, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy adult males and females at least 18 years of age

- Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator or designee's opinion, interfere with study assessments

- Subject has no signs of irritation (i.e., a Reaction Grade of "0") at patch application sites on the back prior to the initial patch application on Day 1

- Subject must have read, understood, and signed the informed consent form prior to any study-related procedure being performed

- Subject is willing and able to comply with all scheduled study visits, urine pregnancy tests (if applicable), contraception requirements (male and female), and other study requirements

- Subject is willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study

Exclusion Criteria:

- Women who are pregnant or lactating

- Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period that includes double barrier, IUD, or hormonal contraceptive combined with single barrier, or abstinence

- Women of childbearing potential who have had unprotected sexual intercourse within 30 days prior to Day 1

- Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use double barrier or whose partner is not using a highly effective method of birth control (e.g., IUD, or hormonal contraception combined with single barrier)

- Subject has any skin condition that, in the Investigator's opinion, could interfere with the study assessments or put the subject at undue risk by study participation

- Subject has severe atopic dermatitis/eczema, psoriasis or chronic asthma

- Subject has tattoos, excessive hair, moles, scarring, etc. which would interfere with patching

- Subject has a history of sensitivity to any component of any of the Test Materials

- Use of any of the following medications:

- Systemic or topical glucocorticoids within 4 weeks prior to Day 1

- Systemic or topical analgesics (e.g., NSAIDs, high dose aspirin, etc.) within 1 week prior to Day 1. Note: Daily use of =325 mg of aspirin for cardiovascular disease or prophylaxis is allowed. Maximum daily use of Tylenol =3000 mg is allowed.

- Antihistamines within 1 week prior to Day 1. Note: H2 blockers such as Pepcid, Zantac, and Tagamet are permitted.

- Anti-inflammatories within 1 week prior to Day 1

- Immunosuppressant medications (e.g., TNF-alpha inhibitors, topical tacrolimus, etc.) within 4 weeks prior to Day 1 (or within 6 half-lives prior to Day 1 for biologics)

- Subject has had previous treatment with SM04755

- Subject has an active infection of hepatitis B or C or human immunodeficiency virus (HIV) infection as determined by an interview

- Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 8 weeks prior to Screening, or planned participation in any such trial; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 8 weeks prior to Screening

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SM04755
Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
Other:
Vehicle
Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
White Petrolatum
Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
Sodium lauryl sulfate
Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

Locations

Country Name City State
United States Research Site Lynchburg Virginia

Sponsors (1)

Lead Sponsor Collaborator
Samumed LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Contact sensitization potential of Test Material as measured by Treatment emergent Baseline to Day 40 (or through the observation period for TEAEs)
Primary Contact sensitization potential of Test Material as measured by Reaction Grade Reaction Grade is measured on a 5-point scale from zero to four (zero = no sign of irritation and 4 = Erythema with edema and blistering) Baseline to Day 38-40
Primary Contact sensitization potential of Test Material as measured by Investigator assessment of irritation and sensitization Baseline to Day 40
See also
  Status Clinical Trial Phase
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT03307499 - NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery N/A
Completed NCT02499484 - Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy N/A
Completed NCT01944150 - Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis N/A
Recruiting NCT04578418 - Effect of Collagen Supplementation on Tendinopathy N/A
Completed NCT03262181 - The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy N/A
Recruiting NCT04278833 - Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions Phase 4
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Recruiting NCT05603468 - Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair Phase 4
Terminated NCT01544244 - The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis N/A
Recruiting NCT04144946 - Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
Terminated NCT02978833 - Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy Phase 4
Completed NCT03229291 - A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects Phase 1
Recruiting NCT06056440 - Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab) N/A
Recruiting NCT04058509 - Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain N/A
Withdrawn NCT02981394 - Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Active, not recruiting NCT02600910 - Natural History of Shoulder Pathology in Manual Wheelchair Users
Completed NCT04793971 - Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
Not yet recruiting NCT01225497 - Eccentric Exercise for Chronic Mid-portion Achilles Tendinopathy N/A
Completed NCT04067479 - Can Amino Acid Supplementation Augment the Anabolic Response in Tendon After Exercise N/A