Chronic WoundPhase 1/2NCT02577120
Wound Healing Endpoint and Recurrence
A Phase 1/2 study testing Epiceram Skin Barrier Function and Vaseline Petroleum Jelly in people with Chronic Wound and Burn Wound, run by Sashwati Roy at 3 sites in United States.
Trial summary
This study is a continuation of a previously approved protocol conducted at Ohio State University and Indiana University. The first two aims of the original protocol have been completed, and this protocol will finish enrollment for the third aim, comparing Hi TEWL and Low TEWL measurements, and whether a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wound, Burn Wound, Diabetic Foot Ulcers
- What is being tested?
- Epiceram Skin Barrier Function and Vaseline Petroleum Jelly
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jan 2019to Feb 2034
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18
- Willing to comply with protocol instructions, including all study visits and study activities.
- One of the following: Healed wound (within 10 days prior to consent/screening visit) that was previously a chronic wound of multiple etiologies and open for at least30 days, including:
- Diabetic foot ulcers, Wagner grade 1-3 ii. Pressure ulcers, stage 2-3 iii. Venous leg ulcers, confirmed by venous duplex iv. Burn wounds
- If candidate has a diabetic foot ulcer, ABI score measurement at Visit 1 must be between 0.7 and 1.2. If score is below or above, candidate will be considered a screen fail. Score can be gathered from EMR in previous 3 months to visit 1 if done as SOC or completed during visit 1.
Who cannot join
- Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent).
- Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients and cancer patients and patients with autoimmune disease on immunosuppressive medications).
- Wounds closed or to be closed by flap or graft coverage - including stage 4pressure ulcers and Wagner grade 4 or 5 diabetic foot ulcers.
- Prisoners
- Patients with allergies to petrolatum
- Patients who are currently enrolled in another research study which includes investigational treatment and/or medication
- Patients with an HbA1c score greater than 10.0 at Visit 1, will be considered a screen fail. Score can be gathered from EMR in previous 12 months to visit 1 if done as SOC, or completed during visit 1.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Pittsburgh / McKeesport Clinic
Pittsburgh, Pennsylvania, 15132
University of Pittsburgh / Mercy Clinic
Pittsburgh, Pennsylvania, 15219
University of Pittsburgh / Passavant
Pittsburgh, Pennsylvania, 16066
About this study
This study is a continuation of a previously approved protocol conducted at Ohio State University and Indiana University. The first two aims of the original protocol have been completed, and this protocol will finish enrollment for the third aim, comparing Hi TEWL and Low TEWL measurements, and whether a HiTEWLmeasurement indicates a seemingly healed wound is more likely to recur/reopen toa new wound.
Of the 105 desired subjects, 62 subjects have already been recruited and completed their study participation at the previous university. 43 additional subjects will be recruited to complete the enrollment goal here at the University of Pittsburgh.
Read the detailed description
In the United States, chronic wounds represent a major public health burden. Estimates put the number of chronic wounds cases at over 6.5 million with a cost burden of over $50 billion14. According to the current standard of care (SoC), wound closure is assessed visually. The FDA defines complete wound closure of chronic non-healing wounds as "skin closure (as assessed visually) without drainage or dressing requirements identified at two consecutive study visits that are 2 weeks apart" and requires therapeutic trials for chronic wounds to be designed such that the enrolled patients will be evaluated for at least 3 months following completeclosure19.
The expectation is that successful intervention should keep the wound closed for at least 90 days. This study contends that visual inspection of wounds is insufficient to certify closure - a critical endpoint that drives treatment decisions. Considering that almost two-thirds of all chronic wounds are estimated to be biofilminfected6, and the observation that biofilm-infected wounds may be visually closed but functionally (barrier function) open, the significance of the proposed hypothesis is substantial.
The proposed study has the clear potential to lay a strong rationale that would potentially change the wound care paradigm by requiring that measurement of skin barrier function be the new endpoint to define wound closure. Reported recurrence rates for most chronic ulcer types remain extremely high, ranging from 40-79%4,5, 24%-57% for venous ulcers, and upward of 60% for diabetic ulcers supporting the importance of preventive efforts1,2. In that context it is of extraordinary significance to ask whether "defective closure" (visually closed with TEWL (Trans-Epidermal Water Loss) >3x the value of intact skin; high TEWL) predicts poor post-closure outcome e.g. recurrence. These questions may only be meaningfully asked in a patient-based pilot and that is exactly the intent of Aim 2. Findings of the proposed pilot will inform a larger future trial.
- Conditions
- Chronic Wound, Burn Wound, Diabetic Foot Ulcers, Pressure Ulcers, Venous Leg Ulcers, Chronic
- Being tested
- Epiceram Skin Barrier Function, Vaseline Petroleum Jelly
- Keywords
- Epiceram
- Medical subject headings
- Burns, Diabetic Foot, Pressure Ulcer, Bronchiolitis Obliterans Syndrome, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiceram Skin Barrier FunctionDevice
Also called Epiceram
Epiceram is a non-sterile, viscous, lipid-rich emulsion
Vaseline Petroleum JellyBiological
Also called Petroleum
A skin protectant used for temporarily protecting minor cuts, scraps, burns, and helps to protect and help relieve chapped or cracked skin and lips.
| Study group | Role | What they receive |
|---|---|---|
| TEWL - Epiceram | Experimental | Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects Receives: Device: Epiceram Skin Barrier Function |
| TEWL - Vaseline Petroleum Jelly | Placebo comparator | Subjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects Receives: Biological: Vaseline Petroleum Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEWL
If topical application of the FDA approved EpiCeram® restores barrier function (TEWL) defectively closed wounds. These will be compared to a Placebo cream, Vaseline and will be seen after 3 months of application to the wound site.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start8 Jan 2019
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sashwati Roy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sashwati Roy, University of Pittsburgh
- Investigators
- Sashwati Roy, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577120
- Sponsor's protocol ID
- STUDY24010050
- Status last verified
- Sep 2025
- First submitted
- 26 Jun 2015
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Final processed data will be shared.
Publications
Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993 Jun;233(6):485-91. doi: 10.1111/j.1365-2796.1993.tb01003.x.
PubMed 8501419Barwell JR, Taylor M, Deacon J, Ghauri AS, Wakely C, Phillips LK, Whyman MR, Poskitt KR. Surgical correction of isolated superficial venous reflux reduces long-term recurrence rate in chronic venous leg ulcers. Eur J Vasc Endovasc Surg. 2000 Oct;20(4):363-8. doi: 10.1053/ejvs.2000.1196.
PubMed 11035968Brooks B, Dean R, Patel S, Wu B, Molyneaux L, Yue DK. TBI or not TBI: that is the question. Is it better to measure toe pressure than ankle pressure in diabetic patients? Diabet Med. 2001 Jul;18(7):528-32. doi: 10.1046/j.1464-5491.2001.00493.x.
PubMed 11553180Chamlin SL, Kao J, Frieden IJ, Sheu MY, Fowler AJ, Fluhr JW, Williams ML, Elias PM. Ceramide-dominant barrier repair lipids alleviate childhood atopic dermatitis: changes in barrier function provide a sensitive indicator of disease activity. J Am Acad Dermatol. 2002 Aug;47(2):198-208. doi: 10.1067/mjd.2002.124617.
PubMed 12140465Disa JJ, Carlton JM, Goldberg NH. Efficacy of operative cure in pressure sore patients. Plast Reconstr Surg. 1992 Feb;89(2):272-8. doi: 10.1097/00006534-199202000-00012.
PubMed 1732895Goodman CM, Cohen V, Armenta A, Thornby J, Netscher DT. Evaluation of results and treatment variables for pressure ulcers in 48 veteran spinal cord-injured patients. Ann Plast Surg. 1999 Jun;42(6):665-72. doi: 10.1097/00000637-199906000-00015.
PubMed 10382806James GA, Swogger E, Wolcott R, Pulcini Ed, Secor P, Sestrich J, Costerton JW, Stewart PS. Biofilms in chronic wounds. Wound Repair Regen. 2008 Jan-Feb;16(1):37-44. doi: 10.1111/j.1524-475X.2007.00321.x. Epub 2007 Dec 13.
PubMed 18086294Lavrijsen AP, Higounenc IM, Weerheim A, Oestmann E, Tuinenburg EE, Bodde HE, Ponec M. Validation of an in vivo extraction method for human stratum corneum ceramides. Arch Dermatol Res. 1994;286(8):495-503. doi: 10.1007/BF00371579.
PubMed 7864665Lopez D, Vlamakis H, Kolter R. Generation of multiple cell types in Bacillus subtilis. FEMS Microbiol Rev. 2009 Jan;33(1):152-63. doi: 10.1111/j.1574-6976.2008.00148.x. Epub 2008 Nov 19.
PubMed 19054118Park SC, Choi CY, Ha YI, Yang HE. Utility of Toe-brachial Index for Diagnosis of Peripheral Artery Disease. Arch Plast Surg. 2012 May;39(3):227-31. doi: 10.5999/aps.2012.39.3.227. Epub 2012 May 10.
PubMed 22783531Pinnagoda J, Tupker RA, Agner T, Serup J. Guidelines for transepidermal water loss (TEWL) measurement. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1990 Mar;22(3):164-78. doi: 10.1111/j.1600-0536.1990.tb01553.x.
PubMed 2335090Romanos MT, Raspovic A, Perrin BM. The reliability of toe systolic pressure and the toe brachial index in patients with diabetes. J Foot Ankle Res. 2010 Dec 22;3:31. doi: 10.1186/1757-1146-3-31.
PubMed 21176166Roy S, Elgharably H, Sinha M, Ganesh K, Chaney S, Mann E, Miller C, Khanna S, Bergdall VK, Powell HM, Cook CH, Gordillo GM, Wozniak DJ, Sen CK. Mixed-species biofilm compromises wound healing by disrupting epidermal barrier function. J Pathol. 2014 Aug;233(4):331-343. doi: 10.1002/path.4360. Epub 2014 May 27.
PubMed 24771509Roy S, Patel D, Khanna S, Gordillo GM, Biswas S, Friedman A, Sen CK. Transcriptome-wide analysis of blood vessels laser captured from human skin and chronic wound-edge tissue. Proc Natl Acad Sci U S A. 2007 Sep 4;104(36):14472-7. doi: 10.1073/pnas.0706793104. Epub 2007 Aug 29.
PubMed 17728400Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.
PubMed 19903300
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing Endpoint and Recurrence
- ClinicalTrials.gov ID
- NCT02577120
- Acronym / sponsor ID
- STUDY24010050
- Conditions
- Chronic Wound, Burn Wound, Diabetic Foot Ulcers, Pressure Ulcers, Venous Leg Ulcers, Chronic
- Keywords
- Epiceram
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sashwati RoyUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2034 (estimated)
- First posted
- 16 Oct 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.
This study is a continuation of a previously approved protocol conducted at Ohio State University and Indiana University. The first two aims of the original protocol have been completed, and this protocol will finish enrollment for the third aim, comparing Hi TEWL and Low TEWL measurements, and whether a HiTEWLmeasurement indicates a seemingly healed wound is more likely to recur/reopen toa new wound.
Of the 105 desired subjects, 62 subjects have already been recruited and completed their study participation at the previous university. 43 additional subjects will be recruited to complete the enrollment goal here at the University of Pittsburgh.
Detailed description
In the United States, chronic wounds represent a major public health burden. Estimates put the number of chronic wounds cases at over 6.5 million with a cost burden of over $50 billion14. According to the current standard of care (SoC), wound closure is assessed visually. The FDA defines complete wound closure of chronic non-healing wounds as "skin closure (as assessed visually) without drainage or dressing requirements identified at two consecutive study visits that are 2 weeks apart" and requires therapeutic trials for chronic wounds to be designed such that the enrolled patients will be evaluated for at least 3 months following completeclosure19.
The expectation is that successful intervention should keep the wound closed for at least 90 days. This study contends that visual inspection of wounds is insufficient to certify closure - a critical endpoint that drives treatment decisions. Considering that almost two-thirds of all chronic wounds are estimated to be biofilminfected6, and the observation that biofilm-infected wounds may be visually closed but functionally (barrier function) open, the significance of the proposed hypothesis is substantial.
The proposed study has the clear potential to lay a strong rationale that would potentially change the wound care paradigm by requiring that measurement of skin barrier function be the new endpoint to define wound closure. Reported recurrence rates for most chronic ulcer types remain extremely high, ranging from 40-79%4,5, 24%-57% for venous ulcers, and upward of 60% for diabetic ulcers supporting the importance of preventive efforts1,2. In that context it is of extraordinary significance to ask whether "defective closure" (visually closed with TEWL (Trans-Epidermal Water Loss) >3x the value of intact skin; high TEWL) predicts poor post-closure outcome e.g. recurrence. These questions may only be meaningfully asked in a patient-based pilot and that is exactly the intent of Aim 2. Findings of the proposed pilot will inform a larger future trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEWL - Epiceram | Experimental | Device: Epiceram Skin Barrier FunctionSubjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects |
| TEWL - Vaseline Petroleum Jelly | Placebo comparator | Biological: Vaseline Petroleum JellySubjects will have the TEWL reading completed at the wound site and a control site (anatomically matched site on the patients contralateral side) at the second study visit. If the wound site reading is less than 3 times the value of the control site subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Willing to comply with protocol instructions, including all study visits and study activities.
- One of the following: Healed wound (within 10 days prior to consent/screening visit) that was previously a chronic wound of multiple etiologies and open for at least30 days, including:
- If candidate has a diabetic foot ulcer, ABI score measurement at Visit 1 must be between 0.7 and 1.2. If score is below or above, candidate will be considered a screen fail. Score can be gathered from EMR in previous 3 months to visit 1 if done as SOC or completed during visit 1.
Key exclusion criteria (7 listed)
- Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent).
- Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients and cancer patients and patients with autoimmune disease on immunosuppressive medications).
- Wounds closed or to be closed by flap or graft coverage - including stage 4pressure ulcers and Wagner grade 4 or 5 diabetic foot ulcers.
- Prisoners
- Patients with allergies to petrolatum
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 |
|---|---|---|
| Epiceram Skin Barrier FunctionAlso: EpiceramEpiceram is a non-sterile, viscous, lipid-rich emulsion | Device | TEWL - Epiceram |
| Vaseline Petroleum JellyAlso: PetroleumA skin protectant used for temporarily protecting minor cuts, scraps, burns, and helps to protect and help relieve chapped or cracked skin and lips. | Biological | TEWL - Vaseline Petroleum Jelly |
Primary outcome
TEWL
Time frame: 12 weeks
If topical application of the FDA approved EpiCeram® restores barrier function (TEWL) defectively closed wounds. These will be compared to a Placebo cream, Vaseline and will be seen after 3 months of application to the wound site.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 8501419Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993 Jun;233(6):485-91. doi: 10.1111/j.1365-2796.1993.tb01003.x.
- Background: PubMed 11035968Barwell JR, Taylor M, Deacon J, Ghauri AS, Wakely C, Phillips LK, Whyman MR, Poskitt KR. Surgical correction of isolated superficial venous reflux reduces long-term recurrence rate in chronic venous leg ulcers. Eur J Vasc Endovasc Surg. 2000 Oct;20(4):363-8. doi: 10.1053/ejvs.2000.1196.
- Background: PubMed 11553180Brooks B, Dean R, Patel S, Wu B, Molyneaux L, Yue DK. TBI or not TBI: that is the question. Is it better to measure toe pressure than ankle pressure in diabetic patients? Diabet Med. 2001 Jul;18(7):528-32. doi: 10.1046/j.1464-5491.2001.00493.x.
- Background: PubMed 12140465Chamlin SL, Kao J, Frieden IJ, Sheu MY, Fowler AJ, Fluhr JW, Williams ML, Elias PM. Ceramide-dominant barrier repair lipids alleviate childhood atopic dermatitis: changes in barrier function provide a sensitive indicator of disease activity. J Am Acad Dermatol. 2002 Aug;47(2):198-208. doi: 10.1067/mjd.2002.124617.
- Background: PubMed 1732895Disa JJ, Carlton JM, Goldberg NH. Efficacy of operative cure in pressure sore patients. Plast Reconstr Surg. 1992 Feb;89(2):272-8. doi: 10.1097/00006534-199202000-00012.
- Background: PubMed 10382806Goodman CM, Cohen V, Armenta A, Thornby J, Netscher DT. Evaluation of results and treatment variables for pressure ulcers in 48 veteran spinal cord-injured patients. Ann Plast Surg. 1999 Jun;42(6):665-72. doi: 10.1097/00000637-199906000-00015.
- Background: PubMed 18086294James GA, Swogger E, Wolcott R, Pulcini Ed, Secor P, Sestrich J, Costerton JW, Stewart PS. Biofilms in chronic wounds. Wound Repair Regen. 2008 Jan-Feb;16(1):37-44. doi: 10.1111/j.1524-475X.2007.00321.x. Epub 2007 Dec 13.
- Background: PubMed 7864665Lavrijsen AP, Higounenc IM, Weerheim A, Oestmann E, Tuinenburg EE, Bodde HE, Ponec M. Validation of an in vivo extraction method for human stratum corneum ceramides. Arch Dermatol Res. 1994;286(8):495-503. doi: 10.1007/BF00371579.
- Background: PubMed 19054118Lopez D, Vlamakis H, Kolter R. Generation of multiple cell types in Bacillus subtilis. FEMS Microbiol Rev. 2009 Jan;33(1):152-63. doi: 10.1111/j.1574-6976.2008.00148.x. Epub 2008 Nov 19.
- Background: PubMed 22783531Park SC, Choi CY, Ha YI, Yang HE. Utility of Toe-brachial Index for Diagnosis of Peripheral Artery Disease. Arch Plast Surg. 2012 May;39(3):227-31. doi: 10.5999/aps.2012.39.3.227. Epub 2012 May 10.
- Background: PubMed 2335090Pinnagoda J, Tupker RA, Agner T, Serup J. Guidelines for transepidermal water loss (TEWL) measurement. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1990 Mar;22(3):164-78. doi: 10.1111/j.1600-0536.1990.tb01553.x.
- Background: PubMed 21176166Romanos MT, Raspovic A, Perrin BM. The reliability of toe systolic pressure and the toe brachial index in patients with diabetes. J Foot Ankle Res. 2010 Dec 22;3:31. doi: 10.1186/1757-1146-3-31.
- Individual participant dataSharing planned: Yes. Final processed data will be shared.
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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.
Sashwati Roy, PhD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epiceram Skin Barrier Function and Vaseline Petroleum Jelly in people with Chronic Wound and Burn Wound, run by Sashwati Roy at 3 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this combined 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
TEWL (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577120, which also lists 21 linked publications.
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 26 Sep 2025.