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Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis

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ClinicalTrials.gov Identifier: NCT01111123
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)
Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment
Enrollment 55
Recruitment Details This trial was conducted at the outpatient clinic of the MSSM Department of Dermatology Clinical Trials Center, in New York, New York, from January 2009 to March 2010. Recruitment was through: advertisements, referrals from the Dermatology Faculty Practice Associates, and through voluntary faculty and dermatology residents.
Pre-assignment Details Patients who were pregnant/nursing, those on biological or other systemic treatments or other systemic treatments in previous three months, those on topical therapies other than emollients in the past one month, those with pre-existing overt atrophy/telangiectasia in treatment areas were excluded.
Arm/Group Title Lac-hydrin + Ultravate Lac Hydrin + Placebo
Hide Arm/Group Description Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
Period Title: Open- Label Phase
Started 55 0
Completed 41 0
Not Completed 14 0
Reason Not Completed
Failed to be clear or almost cleared             14             0
Period Title: Maintenance Phase
Started 21 20
Completed 21 18
Not Completed 0 2
Reason Not Completed
Lost to Follow-up             0             2
Arm/Group Title Lac-hydrin + Ultravate Lac Hydrin + Placebo Total
Hide Arm/Group Description Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
20
 100.0%
41
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
11
  52.4%
10
  50.0%
21
  51.2%
Male
10
  47.6%
10
  50.0%
20
  48.8%
1.Primary Outcome
Title Physical Global Assessment
Hide Description Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.
Time Frame During the maintenance phase, from 2 weeks up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary endpoint was a change in PGA during the 24 weeks of the study in the intention-to-treat population (ITT).
Arm/Group Title Ammonium Lactate + Ultravate Ammoium Lactate + Placebo
Hide Arm/Group Description:
ammonium lactate twice daily everyday plus ultravte ointment twice daily on weekends only for up to 24 weeks
ammonium lactate twice daily everyday plus placebo ointment twice daily weekends only
Overall Number of Participants Analyzed 21 20
Measure Type: Number
Unit of Measure: participants
Category 0 or 1 12 0
Category ≥ 2 9 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ammonium Lactate + Ultravate, Ammoium Lactate + Placebo
Comments Probabilities of PGA not worsening were estimated using the Kaplan-Meier product limit method with a comparison between treatment group survival curves evaluated by the log-rank test statistic. The Cox proportional hazards model was used to estimate the hazard ratio for worsening of PGA (equivalent to a relative risk adjusted for follow-up time) and a corresponding 95-percent confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments CI of 95%
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Signs of Psoriasis, Atrophy or Telangiectasis
Hide Description Signs of psoriasis (erythema, induration, and scale) - physician's assessment of the severity of each of the three key characteristics of psoriatic lesions rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe, combined into one score.
Time Frame During the maintenance phase, from 2 weeks up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary endpoint was a change in PGA during the 24 weeks of the study in the ITT.
Arm/Group Title Lac-hydrin + Ultravate Lac-hydrin + Placebo
Hide Arm/Group Description:
ammonium lactate twice daily everyday + ultravate twice daily weekends only
lac hydrin twice daily everyday plus placebo ointment twice daily weekends only
Overall Number of Participants Analyzed 21 20
Measure Type: Number
Unit of Measure: participants
category 0 or 1 12 0
category ≥ 2 9 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lac-hydrin + Ultravate, Lac-hydrin + Placebo
Comments Secondary outcomes, including subject self-assessment and signs of psoriasis ratings, were analyzed as continuous dependent variables in these statistical models. Mixed modeling analysis of covariance (ANCOVA) was used to compare the relationships between psoriasis symptoms over time in the placebo and steroid treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse events (AEs) were recorded up to the study total of 26 weeks. No follow-up visits were conducted after study treatment concluded.
Adverse Event Reporting Description There were no reported AEs, including serious AEs, related to study medication throughout the study.
 
Arm/Group Title Lac-hydrin + Ultravate Lac Hydrin + Placebo
Hide Arm/Group Description Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
All-Cause Mortality
Lac-hydrin + Ultravate Lac Hydrin + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lac-hydrin + Ultravate Lac Hydrin + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lac-hydrin + Ultravate Lac Hydrin + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
The maintenance phase did not have a long enough study duration to capture clinically significant changes in disease status in the steroid group since >50 percent of the patients at the end of the 24 weeks still remained in the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jason Emer, MD
Organization: Mount Siani School of Medicine Department of Dermatology
Phone: 2122413288 ext 43288
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01111123     History of Changes
Other Study ID Numbers: GCO 08-1061 0001 01 DE
First Submitted: April 22, 2010
First Posted: April 27, 2010
Results First Submitted: June 15, 2011
Results First Posted: June 24, 2016
Last Update Posted: June 24, 2016