Androgenetic AlopeciaPhase 1NCT02791243
Photosensitization Study in Androgenetic Alopecia
A Phase 1 study testing Finasteride 0.25% in people with Androgenetic Alopecia, run by Polichem S.A. at 1 site in United Kingdom.
Trial summary
This study evaluates the potential for induction of photosensitization by P-3074 0.25% finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a negative control (0.9% sodium chloride, NaCl) Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Finasteride 0.25%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2016to 27 Jun 2016
- Phase
- Phase 1
- 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males aged 18 to 65.
- Good general health, as assessed by verbal medical history and brief physical examination of the skin.
- Fitzpatrick Skin Type I-IV, determined by interview at screening.
- Willing to use a double-barrier methods (for example, a condom or a diaphragm plus spermicide) during sexual intercourse with a female partner while participating in the study.
- Male subjects will need to confirm method and length of time for method of birth control for female partners.
- Fully informed of the risks of entering the study and willing to provide written consent to enter the study.
- Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
- Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating on the study.
Who cannot join
- MED ≤ 2.5 SED for Fitzpatrick Skin Types I and II or MED ≤ 4.0 SED for Fitzpatrick Skin Types III and IV
- Type I Insulin-dependent diabetes
- Mastectomy for cancer involving removal of lymph nodes draining the test site.
- Clinically significant skin diseases which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active skin cancer.
- Use of any photosensitizing medications or supplements, such as but not limited to sulfa drugs, tetracyclines, phenothiazines, thiazides, antiemetics and St. John's Wort.
- Any medical conditions caused or affected by sunlight (UV), such as but not limited to solar urticarial and polymorphous light eruptions.
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- Active immunologic disorders.
- Routine use of anti-inflammatory, immunosuppressive or antihistamine medications (81 mg aspirin is acceptable).
- Participation in a patch test or soap chamber test within the past 4 weeks.
- History of significant sensitivity or allergy to adhesive bandages, tapes, etc.
- Use of finasteride (oral and/or topical), within 6 months prior to the screening visit.
- Contraindications to finasteride therapy or intolerance of finasteride.
- History of sensitivity to skin solution products.
- Hair, tattoos, pigmentation, scars, moles or other conditions at the areas to be patched that may interfere with patch application, tolerability, or postapplication evaluations.
- Participation in a clinical trial or receipt of an investigational medication within 4 weeks of the study.
- Current treatment with allergy injections.
- History of severe asthma.
- Chronic or active liver disease [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5x upper limit of normal (ULN)]
- Neutrophils < 1500 cells/mm3
- Clinically significant chronic illness, which could place the subject at increased risk during participation or result in inappropriate dermal response during the study in the opinion of the Investigator.
- History of alcohol or drug abuse within 1 year of the study.
- Any condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk.
- Judged by the investigator to be unsuitable for any reason.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Princeton Consumer Research Inc.
Chelmsford, Essex, CM2 6UA
About this study
Official title: A Within-subject, Randomized, Evaluator-blinded, Vehicle-controlled Study to Assess the Photosensitization Potential of Finasteride Cutaneous Solution(P-3074) in Human Subjects
This study evaluates the potential for induction of photosensitization by P-3074 0.25% finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a negative control (0.9% sodium chloride, NaCl)
Read the detailed description
Healthy male volunteers, drawn from the general population, will be treated with P-3074 solution, placebo vehicle control and 0.9% sodium chloride USP (negative control) by using 6 induction applications on the back area and Ultraviolet A (UVA)/Ultraviolet B (UVB) irradiations during the 3 week induction period, a 10 day rest period, and a challenge phase of a 24-hour patch application, UVA and UVB irradiation followed by evaluation of photosensitization over the subsequent 72 hours.
- Conditions
- Androgenetic Alopecia
- Being tested
- Finasteride 0.25%, Placebo for Finasteride 0.25%, Negative Control
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finasteride 0.25%Drug
Also called P-3074
Cutaneous solution of finasteride 0.25%
Placebo for Finasteride 0.25%Drug
Also called vehicle cutaneous solution
vehicle cutaneous solution of P-3074
Negative ControlDrug
Also called 0.9% aqueous NaCl
0.9% aqueous NaCl
| Study group | Role | What they receive |
|---|---|---|
| Finasteride 0.25% | Experimental | approximately 0.2 ml of P-3074 (0.25% finasteride) Receives: Drug: Finasteride 0.25% |
| Placebo for Finasteride 0.25% | Placebo comparator | approximately 0.2 ml of the vehicle cutaneous solution Receives: Drug: Placebo for Finasteride 0.25% |
| Negative Control | Other | approximately 0.2 ml of 0.9% aqueous NaCl Receives: Drug: Negative Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential for induction of photosensitization
Measured: from day 4 to day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start9 May 2016
- Primary completionJun 2016
- Study completion27 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polichem S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Carr, MD, Principal investigator, Princeton Consumer Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791243
- Sponsor's protocol ID
- PM1542
- Status last verified
- May 2017
- First submitted
- 1 Jun 2016
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Within-subject, Randomized, Evaluator-blinded, Vehicle-controlled Study to Assess the Photosensitization Potential of Finasteride Cutaneous Solution(P-3074) in Human Subjects
- ClinicalTrials.gov ID
- NCT02791243
- Acronym / sponsor ID
- PM1542
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Polichem S.A.Industry (pharma, biotech, devices)
- Study start
- 9 May 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- 27 Jun 2016 (actual)
- First posted
- 6 Jun 2016 (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.
This study evaluates the potential for induction of photosensitization by P-3074 0.25% finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a negative control (0.9% sodium chloride, NaCl)
Detailed description
Healthy male volunteers, drawn from the general population, will be treated with P-3074 solution, placebo vehicle control and 0.9% sodium chloride USP (negative control) by using 6 induction applications on the back area and Ultraviolet A (UVA)/Ultraviolet B (UVB) irradiations during the 3 week induction period, a 10 day rest period, and a challenge phase of a 24-hour patch application, UVA and UVB irradiation followed by evaluation of photosensitization over the subsequent 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Finasteride 0.25% | Experimental | Drug: Finasteride 0.25%approximately 0.2 ml of P-3074 (0.25% finasteride) |
| Placebo for Finasteride 0.25% | Placebo comparator | Drug: Placebo for Finasteride 0.25%approximately 0.2 ml of the vehicle cutaneous solution |
| Negative Control | Other | Drug: Negative Controlapproximately 0.2 ml of 0.9% aqueous NaCl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males aged 18 to 65.
- Good general health, as assessed by verbal medical history and brief physical examination of the skin.
- Fitzpatrick Skin Type I-IV, determined by interview at screening.
- Willing to use a double-barrier methods (for example, a condom or a diaphragm plus spermicide) during sexual intercourse with a female partner while participating in the study.
- Male subjects will need to confirm method and length of time for method of birth control for female partners.
Key exclusion criteria (23 listed)
- MED ≤ 2.5 SED for Fitzpatrick Skin Types I and II or MED ≤ 4.0 SED for Fitzpatrick Skin Types III and IV
- Type I Insulin-dependent diabetes
- Mastectomy for cancer involving removal of lymph nodes draining the test site.
- Clinically significant skin diseases which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active skin cancer.
- Use of any photosensitizing medications or supplements, such as but not limited to sulfa drugs, tetracyclines, phenothiazines, thiazides, antiemetics and St. John's Wort.
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 |
|---|---|---|
| Finasteride 0.25%Also: P-3074Cutaneous solution of finasteride 0.25% | Drug | Finasteride 0.25% |
| Placebo for Finasteride 0.25%Also: vehicle cutaneous solutionvehicle cutaneous solution of P-3074 | Drug | Placebo for Finasteride 0.25% |
| Negative ControlAlso: 0.9% aqueous NaCl0.9% aqueous NaCl | Drug | Negative Control |
Primary outcome
Potential for induction of photosensitization
Time frame: from day 4 to day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Individual participant dataSharing planned: No
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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.
Michael Carr, MD principal investigator
Princeton Consumer Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Finasteride 0.25% in people with Androgenetic Alopecia, run by Polichem S.A. at 1 site in United Kingdom.
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 8 inclusion and 23 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 18 May 2017. 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 Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Potential for induction of photosensitization (time frame: from day 4 to day 42). 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 18 May 2017.