Chemical PeelEarly Phase 1NCT01135290
Post Treatment Care After Chemical Peel or Laser Resurfacing
A Early Phase 1 study testing Aquaphor and HP828-101 in people with Chemical Peel, run by Healthpoint at 1 site in United States.
Trial summary
This study tests two different approaches to the resolution of facial skin resurfacing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemical Peel
- What is being tested?
- Aquaphor and HP828-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2010
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The informed consent document and photography release must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent and photography release document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
- Subjects 18 years of age or older, scheduled to undergo either a medium chemical peel with 35% TCA or a laser resurfacing. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
- Women of child-bearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal) may participate in the study if they meet all of the following conditions:
- they are not breast feeding
- undertake a pregnancy test, which must be negative
- they do not intend to become pregnant during the study
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- they are using adequate birth control methods and they agree to continue using those methods for the duration of the study
- Adequate birth control methods are defined as: hormonal-topical, oral, implantable, or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or, surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use an adequate birth control method as described above for the remainder of the study.
- NOTE: Women who have had a bilateral tubal ligation are not considered to have been surgically sterilized and must agree to the conditions as specified above.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Undergo a medium grade chemical peel or fractional resurfacing.
Who cannot join
- Contraindications or hypersensitivity to the use of the study medications or their components (e.g., balsam of Peru, castor oil, or phenoxyethanol).
- Therapy with another investigational agent within thirty (30) days of Visit 1, or during the study.
- Have taken anticoagulants (blood thinners, including aspirin) within two weeks.
- Current smoker.
- Use of oral isotretinoin during the past 12 months, systemic steroids, topical retinoids, or topical corticosteroids within the month prior to the study.
- Have any congenital skin disorder which affects keratinocytes, elastin, or collagen.
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- Have any dermatologic disease which may be aggravated or provoked by the wounding procedure.
- Are at risk of keloid or hypertrophic scar formation based on personal or family history, or skin exam.
- Have any skin disorder which causes delayed healing.
- Have any systemic condition that would compromise skin healing.
- The Medical Monitor may declare any subject ineligible for a valid medical reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Evaluation of HP828-101 for Post Treatment Care Following a Chemical Peel or Laser Resurfacing
This study tests two different approaches to the resolution of facial skin resurfacing.
- Conditions
- Chemical Peel
- Being tested
- Aquaphor, HP828-101
- Keywords
- The management of post-treatment symptoms for subjects that had either a medium grade chemical peel or fractional resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaphorDrug
HP828-101Drug
| Study group | Role | What they receive |
|---|---|---|
| B | Other | Not described Receives: Drug: Aquaphor |
| A | Active comparator | Not described Receives: Drug: HP828-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician and subject evaluation ratings of the signs and symptoms of facial skin during post-operative care.
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Why it stopped: Business decision, formulation will not be pursued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemical PeelStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Herbert B Slade, MD, Study chair, HealthpointJeffery Kenkel, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135290
- Sponsor's protocol ID
- 828-101-09-016
- Status last verified
- Sep 2013
- First submitted
- 1 Jun 2010
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HP828-101 for Post Treatment Care Following a Chemical Peel or Laser Resurfacing
- ClinicalTrials.gov ID
- NCT01135290
- Acronym / sponsor ID
- 828-101-09-016
- Conditions
- Chemical Peel
- Keywords
- The management of post-treatment symptoms for subjects that had either a medium grade chemical peel or fractional resurfacing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision, formulation will not be pursued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 2 Jun 2010 (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 tests two different approaches to the resolution of facial skin resurfacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Other | Drug: Aquaphor |
| A | Active comparator | Drug: HP828-101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The informed consent document and photography release must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent and photography release document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
- Subjects 18 years of age or older, scheduled to undergo either a medium chemical peel with 35% TCA or a laser resurfacing. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
- Women of child-bearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal) may participate in the study if they meet all of the following conditions:
- Adequate birth control methods are defined as: hormonal-topical, oral, implantable, or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or, surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use an adequate birth control method as described above for the remainder of the study.
- NOTE: Women who have had a bilateral tubal ligation are not considered to have been surgically sterilized and must agree to the conditions as specified above.
Key exclusion criteria (11 listed)
- Contraindications or hypersensitivity to the use of the study medications or their components (e.g., balsam of Peru, castor oil, or phenoxyethanol).
- Therapy with another investigational agent within thirty (30) days of Visit 1, or during the study.
- Have taken anticoagulants (blood thinners, including aspirin) within two weeks.
- Current smoker.
- Use of oral isotretinoin during the past 12 months, systemic steroids, topical retinoids, or topical corticosteroids within the month prior to 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 |
|---|---|---|
| Aquaphor | Drug | B |
| HP828-101 | Drug | A |
Primary outcome
Physician and subject evaluation ratings of the signs and symptoms of facial skin during post-operative care.
Time frame: 84 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
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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.
Herbert B Slade, MD study chair
Healthpoint
Jeffery Kenkel, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aquaphor and HP828-101 in people with Chemical Peel, run by Healthpoint 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 12 inclusion and 11 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: withdrawn, as of the sponsor's last update on 1 Oct 2013. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Physician and subject evaluation ratings of the signs and symptoms of facial skin during post-operative care. (time frame: 84 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 1 Oct 2013.