Dry SkinNCT04085809
This Was a Clinical Study Investigating the Moisturization and Desquamation Effect of AmLactin® Rapid Relief Restoring Lotion + Ceramides on Dry Skin in Healthy Female Volunteers. AmLactin® Rapid Relief is an Over-the-counter Cosmetic
A study testing AmLactin® Rapid Relief in people with Dry Skin, run by Sandoz at 1 site in United States.
Trial summary
The primary objective of this study was to investigate if AmLactin® Rapid Relief improves the skin through desquamation and moisturization via D-SQUAME analysis. AmLactin® Rapid Relief is an over-the-counter cosmetic. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dry Skin
- What is being tested?
- AmLactin® Rapid Relief
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 8 Apr 2019
- Phase
- Interventional
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy female (confirmed by medical history) with Fitzpatrick skin types I-VI
- dry, rough skin on the anterior shins (defined as Grade 3-4 on the dermatologist evaluation of the skin);
Who cannot join
- Had any visible skin disease at the assessment site which, in the opinion of the Investigator, would interfere with the evaluation of the test site
Trial locations and contacts
1 site in 1 country.
United States1 site
Sandoz Investigational Site
High Point, North Carolina, 27262
About this study
Official title: A 14-Day, Single-Blind, Controlled Study to Assess the Qualitative Improvement in Skin Moisturization and Desquamation of AmLactin® Rapid Relief Treatment in Healthy Female Subjects
The primary objective of this study was to investigate if AmLactin® Rapid Relief improves the skin through desquamation and moisturization via D-SQUAME analysis. AmLactin® Rapid Relief is an over-the-counter cosmetic.
- Conditions
- Dry Skin
- Being tested
- AmLactin® Rapid Relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmLactin® Rapid ReliefOther
AmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic.
| Study group | Role | What they receive |
|---|---|---|
| Left Leg: AmLactin® Rapid Relief / Right Leg: No Treatment | Experimental | AmLactin® Rapid Relief, BID application for 14 days on left leg and no treatment on right leg Receives: Other: AmLactin® Rapid Relief |
| Left Leg: No Treatment / Right Leg: AmLactin® Rapid Relief | Experimental | AmLactin® Rapid Relief, BID application for 14 days on right leg and no treatment on left leg Receives: Other: AmLactin® Rapid Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in D-SQUAME
D-SQUAME is a sticky tape that is placed on the skin and the more skin that comes off on the tape, the drier the skin and less moisturization and desquamation.
Measured: Baseline, Day 2, Day 14
Secondary outcomes (7)
Change from baseline in overall dry skin scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe in five domains.
Measured: Baseline, Day 2, Day 14
Change from baseline in Skin Dryness assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Measured: Baseline, Day 2, Day 14
Change from baseline in Skin Texture/Roughness (Tactile) assessed by Dry Skin Scale assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Measured: Baseline, Day 2, Day 14
Change from baseline in Skin Texture/Roughness (Visual) assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Measured: Baseline, Day 2, Day 14
Change from baseline in Desquamation/Flakiness assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Measured: Baseline, Day 2, Day 14
Change from baseline in Luminosity/Radiance assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Measured: Baseline, Day 2, Day 14
Change from baseline in Subject Self-Assessment Questionnaire
Subjects rated the skin attributes of the treated leg in nine domains on a scale from 0 - 4 .
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start26 Mar 2019
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Upon enrollment, each subject received a randomization code, indicating which leg the study product had to be applied (the other leg received no study product). Each subject in this study served as her own control.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085809
- Sponsor's protocol ID
- 0123-02-01
- Status last verified
- May 2023
- First submitted
- 9 Sep 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Draelos ZD, Hall S, Munsick C. A 14-day Controlled Study Assessing Qualitative Improvement with 15% Lactic Acid and Ceramides in Skin Moisturization and Desquamation. J Clin Aesthet Dermatol. 2020 Aug;13(8):E54-E58. Epub 2020 Aug 1.
PubMed 33178384
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14-Day, Single-Blind, Controlled Study to Assess the Qualitative Improvement in Skin Moisturization and Desquamation of AmLactin® Rapid Relief Treatment in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT04085809
- Acronym / sponsor ID
- 0123-02-01
- Conditions
- Dry Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 11 Sep 2019 (actual)
- 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.
The primary objective of this study was to investigate if AmLactin® Rapid Relief improves the skin through desquamation and moisturization via D-SQUAME analysis. AmLactin® Rapid Relief is an over-the-counter cosmetic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Upon enrollment, each subject received a randomization code, indicating which leg the study product had to be applied (the other leg received no study product). Each subject in this study served as her own control.
| Arm | Type | Receives |
|---|---|---|
| Left Leg: AmLactin® Rapid Relief / Right Leg: No Treatment | Experimental | Other: AmLactin® Rapid ReliefAmLactin® Rapid Relief, BID application for 14 days on left leg and no treatment on right leg |
| Left Leg: No Treatment / Right Leg: AmLactin® Rapid Relief | Experimental | Other: AmLactin® Rapid ReliefAmLactin® Rapid Relief, BID application for 14 days on right leg and no treatment on left leg |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy female (confirmed by medical history) with Fitzpatrick skin types I-VI
- dry, rough skin on the anterior shins (defined as Grade 3-4 on the dermatologist evaluation of the skin);
Key exclusion criteria (1 listed)
- Had any visible skin disease at the assessment site which, in the opinion of the Investigator, would interfere with the evaluation of the test site
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 |
|---|---|---|
| AmLactin® Rapid ReliefAmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic. | Other | Left Leg: AmLactin® Rapid Relief / Right Leg: No Treatment, Left Leg: No Treatment / Right Leg: AmLactin® Rapid Relief |
Primary outcome
Change from baseline in D-SQUAME
Time frame: Baseline, Day 2, Day 14
D-SQUAME is a sticky tape that is placed on the skin and the more skin that comes off on the tape, the drier the skin and less moisturization and desquamation.
7 secondary outcomes
Change from baseline in overall dry skin scale
Time frame: Baseline, Day 2, Day 14
Change from baseline in Skin Dryness assessed by Dry Skin Scale
Time frame: Baseline, Day 2, Day 14
Change from baseline in Skin Texture/Roughness (Tactile) assessed by Dry Skin Scale assessed by Dry Skin Scale
Time frame: Baseline, Day 2, Day 14
Change from baseline in Skin Texture/Roughness (Visual) assessed by Dry Skin Scale
Time frame: Baseline, Day 2, Day 14
Change from baseline in Desquamation/Flakiness assessed by Dry Skin Scale
Time frame: Baseline, Day 2, Day 14
Change from baseline in Luminosity/Radiance assessed by Dry Skin Scale
Time frame: Baseline, Day 2, Day 14
Change from baseline in Subject Self-Assessment Questionnaire
Time frame: Baseline, Day 14
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 10 May 2023.
- Derived from this study: PubMed 33178384Draelos ZD, Hall S, Munsick C. A 14-day Controlled Study Assessing Qualitative Improvement with 15% Lactic Acid and Ceramides in Skin Moisturization and Desquamation. J Clin Aesthet Dermatol. 2020 Aug;13(8):E54-E58. Epub 2020 Aug 1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AmLactin® Rapid Relief in people with Dry Skin, run by Sandoz 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 2 inclusion and 1 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 May 2023. 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.
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?
Change from baseline in D-SQUAME (time frame: Baseline, Day 2, Day 14). 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 NCT04085809, which also lists 1 linked publication.
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 May 2023.