Dry SkinPhase 2/3NCT00368563
A Capacitance and Transepidermal Water Loss Test to Determine the Ability of Sunscreen to Moisturize Skin
A Phase 2/3 study testing Helioblock SX in people with Dry Skin, run by Loreal USA at 1 site in United States.
Trial summary
To evaluate the ability of 2 Helioblock SX Cream formulations to moisturize skin using capacitance and transepidermal water loss methodology Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Dry Skin
- What is being tested?
- Helioblock SX
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Oct 2006
- Phase
- Phase 2/3
- 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 55 years
- All sexes
- Adult
Who may be able to join
- Healthy,male or female subjects 18 years to 55 years of age, with a minimum Stanfield score at baseline of "2" at the forearm sites intended to be assessed in the study
- Female subjects of childbearing potential using a reliable form of contraception during the course of the study(oral contraceptive pill, intrauterine device, bilateral tubal ligation, abstinence, or other reliable forms at the discretion of the Investigator.) or of non childbearing potential(i.e.,post-menopausal(one year without menstrual period), hysterectomy or bilateral ovariectomy)
- Subjects who have read, understood and signed an informed consent
- Subjects who are willing and capable of cooperating to the extent and degree required by the protocol
- Absence of any visible skin diseases which might be confused with a skin reaction from the test material
Who cannot join
- Subjects with a condition, or in a situation, which in the Investigator's or Sub-Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or may interfere with the subject's participation in the study.
- Subjects with known sensitivities to any of the study preparations or to other skin care products
- Subjects who have participated in a clinical research study, including consumer products studies, within the last 30 days prior to enrollment
- Subjects who are currently receiving medication(prescription or OTC) that in the opinion of the Investigator may interfere with the evaluations made in this study (e.g.vasoactive substances)
- Pregnant or nursing females or women who are planning to get pregnant during the study
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the ability of 2 Helioblock SX Cream formulations to moisturize skin using capacitance and transepidermal water loss methodology
- Conditions
- Dry Skin
- Being tested
- Helioblock SX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helioblock SXDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies 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 2/3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Loreal USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Linda Oddo, B.S., Principal investigator, Hill Top Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368563
- Sponsor's protocol ID
- PEN.1010.02
- Status last verified
- Feb 2009
- First submitted
- 23 Aug 2006
- Last updated
- 11 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Capacitance and Transepidermal Water Loss Test to Determine the Ability of Sunscreen to Moisturize Skin
- ClinicalTrials.gov ID
- NCT00368563
- Acronym / sponsor ID
- PEN.1010.02
- Conditions
- Dry Skin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Loreal USAIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 24 Aug 2006 (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.
To evaluate the ability of 2 Helioblock SX Cream formulations to moisturize skin using capacitance and transepidermal water loss methodology
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy,male or female subjects 18 years to 55 years of age, with a minimum Stanfield score at baseline of "2" at the forearm sites intended to be assessed in the study
- Female subjects of childbearing potential using a reliable form of contraception during the course of the study(oral contraceptive pill, intrauterine device, bilateral tubal ligation, abstinence, or other reliable forms at the discretion of the Investigator.) or of non childbearing potential(i.e.,post-menopausal(one year without menstrual period), hysterectomy or bilateral ovariectomy)
- Subjects who have read, understood and signed an informed consent
- Subjects who are willing and capable of cooperating to the extent and degree required by the protocol
- Absence of any visible skin diseases which might be confused with a skin reaction from the test material
Key exclusion criteria (5 listed)
- Subjects with a condition, or in a situation, which in the Investigator's or Sub-Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or may interfere with the subject's participation in the study.
- Subjects with known sensitivities to any of the study preparations or to other skin care products
- Subjects who have participated in a clinical research study, including consumer products studies, within the last 30 days prior to enrollment
- Subjects who are currently receiving medication(prescription or OTC) that in the opinion of the Investigator may interfere with the evaluations made in this study (e.g.vasoactive substances)
- Pregnant or nursing females or women who are planning to get pregnant during the study
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 |
|---|---|---|
| Helioblock SX | Drug | – |
Primary outcome
Not reported in the source record.
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 11 Feb 2009.
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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.
Linda Oddo, B.S. principal investigator
Hill Top Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Helioblock SX in people with Dry Skin, run by Loreal USA 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 5 inclusion and 5 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 11 Feb 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 11 Feb 2009.