VitiligoNCT01992185
Photocil (Topical) for the Treatment of Vitiligo
A study testing Photocil for Vitiligo in people with Vitiligo, run by Applied Biology, Inc. at 1 site in United States.
Trial summary
Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Photocil for Vitiligo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with vitiligo confirmed by a dermatologist
- Vitiligo lesions affecting at a minimum 5% of the facial, legs, or arms surface area
- Age: 18 to 65
- Participants able to give informed consent
Who cannot join
- Subject did not respond to prior phototherapy treatment
- Subject completed phototherapy for same lesion(s) in last 6 months
- Subject has previous history of skin cancer
- Subject has previous history of photosensitivity
- Subject has a history of herpes (HSV I or II) outbreaks
- Subject has previous history of autoimmune disease may be excluded at investigator's discretion
Show all 9Show fewer
- Subject is currently taking of immunosuppressive or photosensitizing drugs
- Subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. These patients may be excluded at investigator's discretion
- Subject is pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Vitiligo
Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of vitiligo.
Read the detailed description
NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Vitiligo Area Severity Index (VASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.
Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.
In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.
- Conditions
- Vitiligo
- Being tested
- Photocil for Vitiligo, Placebo - Sunscreen (SPF 2)
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photocil for VitiligoDrug
Also called Photocil for Vitiligo (U.S. FDA NDC: 54841-001-01)
Photocil for Vitiligo
Placebo - Sunscreen (SPF 2)Other
Placebo - Sunscreen (SPF 2)
| Study group | Role | What they receive |
|---|---|---|
| Photocil for Vitiligo | Active comparator | Active Drug - Photocil for Vitiligo Receives: Drug: Photocil for Vitiligo |
| Placebo - Sunscreen (SPF 2) | Placebo comparator | Placebo - Sunscreen (SPF 2) Receives: Other: Placebo - Sunscreen (SPF 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Repigmentation
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VitiligoStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McCoy, PhD, Study director, Applied Biology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992185
- Sponsor's protocol ID
- AB-DRUG-PHOTOCIL-VT-001
- Status last verified
- Feb 2016
- First submitted
- 19 Nov 2013
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT01992185
- Acronym / sponsor ID
- AB-DRUG-PHOTOCIL-VT-001
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 10 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of vitiligo.
Detailed description
NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Vitiligo Area Severity Index (VASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.
Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.
In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photocil for Vitiligo | Active comparator | Drug: Photocil for VitiligoActive Drug - Photocil for Vitiligo |
| Placebo - Sunscreen (SPF 2) | Placebo comparator | Other: Placebo - Sunscreen (SPF 2)Placebo - Sunscreen (SPF 2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with vitiligo confirmed by a dermatologist
- Vitiligo lesions affecting at a minimum 5% of the facial, legs, or arms surface area
- Age: 18 to 65
- Participants able to give informed consent
Key exclusion criteria (9 listed)
- Subject did not respond to prior phototherapy treatment
- Subject completed phototherapy for same lesion(s) in last 6 months
- Subject has previous history of skin cancer
- Subject has previous history of photosensitivity
- Subject has a history of herpes (HSV I or II) outbreaks
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 |
|---|---|---|
| Photocil for VitiligoAlso: Photocil for Vitiligo (U.S. FDA NDC: 54841-001-01)Photocil for Vitiligo | Drug | Photocil for Vitiligo |
| Placebo - Sunscreen (SPF 2)Placebo - Sunscreen (SPF 2) | Other | Placebo - Sunscreen (SPF 2) |
Primary outcome
Percent Repigmentation
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John McCoy, PhD study director
Applied Biology, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photocil for Vitiligo in people with Vitiligo, run by Applied Biology, Inc. at 1 site in United States.
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 9 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: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Repigmentation (time frame: 90 days). 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 10 Mar 2016.