Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02636244
• Other study ID #: SHP-141-POC-0004-PTL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 15, 2015
• Last updated: October 18, 2016
• Start date: February 2017
• Est. completion date: January 2018

Study information

• Verified date: October 2016
• Source: TetraLogic Pharmaceuticals
• Contact: Judith Schnyder
• Phone: 610-889-9900
• Email: jschnyder[@]tlog.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• SHAPE Gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TetraLogic Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes