Alopecia AreataPhase 2NCT02636244
Safety and Efficacy Study of SHAPE Gel in Alopecia Areata
A Phase 2 study testing SHAPE Gel in people with Alopecia Areata, run by TetraLogic Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- SHAPE Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- SHAPE Gel
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAPE GelDrug
Also called SHP-141
| Study group | Role | What they receive |
|---|---|---|
| SHAPE Gel | Experimental | 1% SHAPE Gel applied twice daily for 12 weeks. Receives: Drug: SHAPE Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 4 weeks; up to 24 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Every 4 weeks, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startFeb 2017
- Primary completionAug 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TetraLogic Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636244
- Sponsor's protocol ID
- SHP-141-POC-0004-PTL
- Status last verified
- Oct 2016
- First submitted
- 15 Dec 2015
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02636244
- Acronym / sponsor ID
- SHP-141-POC-0004-PTL
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- TetraLogic PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2017
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHAPE Gel | Experimental | Drug: SHAPE Gel1% SHAPE Gel applied twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHAPE GelAlso: SHP-141 | Drug | SHAPE Gel |
Primary outcome
Response evaluated using modified Severity of Alopecia Tool (mSALT)
Time frame: Every 4 weeks; up to 24 weeks
Severity of Alopecia Tool (SALT) estimates percent scalp hair loss and percent regrowth of hair following intervention
4 secondary outcomes
Effects on quality of life using Subject Assessment of Hair Loss (SAHL)
Time frame: Every 4 weeks; up to 24 weeks
Effects on quality of life using Alopecia Areata Symptom Impact Scale (AASIS)
Time frame: Every 4 weeks; up to 24 weeks
Effects on quality of life using the Skindex-16
Time frame: Every 4 weeks; up to 24 weeks
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Time frame: Every 4 weeks, up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHAPE Gel in people with Alopecia Areata, run by TetraLogic Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith Schnyder (610-889-9900 ext. 151, jschnyder@tlog.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response evaluated using modified Severity of Alopecia Tool (mSALT) (time frame: Every 4 weeks; up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.