Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

A Multi-Center, Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of SHAPE Gel, a Histone Deacetylase Inhibitor, in Patients With Alopecia Areata

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.

Study Overview

• Status: Unknown
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: SHAPE Gel

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Judith Schnyder; Phone Number: 151 610-889-9900; Email: jschnyder@tlog.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHAPE Gel; 1% SHAPE Gel applied twice daily for 12 weeks.	Drug: SHAPE Gel; Other Names: SHP-141

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on quality of life using Subject Assessment of Hair Loss (SAHL)	The SAHL compares baseline hair volume and hair density with end of treatment hair volume and density	Every 4 weeks; up to 24 weeks
Effects on quality of life using Alopecia Areata Symptom Impact Scale (AASIS)	AASIS rates the severity of alopecia areata symptoms and interference of alopecia areata with daily functioning	Every 4 weeks; up to 24 weeks
Effects on quality of life using the Skindex-16	Skindex-16 assesses how often symptoms or signs of alopecia areata have been bothersome	Every 4 weeks; up to 24 weeks
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)	Evaluation of safety and tolerability will be assessed through adverse events (AEs), vital signs, physical examination, assessment of local skin changes and changes in clinical laboratory parameters	Every 4 weeks, up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic effect determined through assessment of lymphocyte subsets	Measured by CD3, CD4 and CD8 lymphocytes in skin as well as by other assessments of immune modulation in the scalp	Up to 12 weeks

Collaborators and Investigators

• Sponsor: TetraLogic Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: SHP-141-POC-0004-PTL