Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

NCT02636244 | Unknown Phase 2

• 1 other identifier: SHP-141-POC-0004-PTL
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied topically to adult patients with alopecia areata of the scalp.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Response evaluated using modified Severity of Alopecia Tool (mSALT)

  Severity of Alopecia Tool (SALT) estimates percent scalp hair loss and percent regrowth of hair following intervention

  Every 4 weeks; up to 24 weeks

Secondary Outcomes (4)

• Effects on quality of life using Subject Assessment of Hair Loss (SAHL)

  Every 4 weeks; up to 24 weeks

• Effects on quality of life using Alopecia Areata Symptom Impact Scale (AASIS)

  Every 4 weeks; up to 24 weeks

• Effects on quality of life using the Skindex-16

  Every 4 weeks; up to 24 weeks

• Incidence of Treatment-Emergent Adverse Events (safety and tolerability)

  Every 4 weeks, up to 12 weeks

Other Outcomes (1)

• Pharmacodynamic effect determined through assessment of lymphocyte subsets

  Up to 12 weeks

Study Arms (1)

SHAPE Gel

EXPERIMENTAL

1% SHAPE Gel applied twice daily for 12 weeks.

Drug: SHAPE Gel

Interventions

SHAPE Gel DRUG

Also known as: SHP-141

SHAPE Gel

Eligibility Criteria

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

You may qualify if:

• Diagnosis of scalp alopecia areata and scalp hair loss due to alopecia areata for a minimum of six months and a maximum of two years.
• Patients taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study.
• Willingness to maintain same hair style, including shampoo and hair dye, throughout the study period.
• Willingness to have a small micro dot tattoo placed to allow for photographic analysis of treatment and application of study medication.

You may not qualify if:

• History of systemic or cutaneous malignancy and/or lymphoproliferative disease, other than patients with: up to 3 basal cell carcinoma; up to three well differentiated cutaneous squamous cell carcinoma; and/or cervical intraepithelial neoplasm (CIN), treated successfully with no evidence of disease, and treated for greater than 6 months prior to study entry.
• Current actinic keratosis on the scalp and/or face
• Nevi or cutaneous lesions thought suspicious for malignancy.
• History of or current gastrointestinal, pulmonary, cardiovascular, genitourinary or hematological disease, CNS disorders, infectious disease or coagulation disorders that would preclude participation in and completion of study assessments.
• Positive for hepatitis B surface antigen, HIV or hepatitis C.
• Co-existent androgenetic alopecia: in males: Norwood-Hamilton stage IV, V or VI; in females: Ludwig stage II or III.
• Unwillingness to discontinue use of non-breathable wigs, weaves or shaving of scalp throughout course of study.

Sponsors & Collaborators

• TetraLogic Pharmaceuticals: lead

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Judith Schnyder

CONTACT

610-889-9900; jschnyder@tlog.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: February 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 20, 2016

Record last verified: 2016-10