Trial Outcomes & Findings for Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis (NCT NCT01111123)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

55 participants

Primary outcome timeframe

During the maintenance phase, from 2 weeks up to 26 weeks

Results posted on

2016-06-24

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Lac-hydrin + Ultravate Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks	Lac Hydrin + Placebo Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
Open- Label Phase STARTED	55	0
Open- Label Phase COMPLETED	41	0
Open- Label Phase NOT COMPLETED	14	0
Maintenance Phase STARTED	21	20
Maintenance Phase COMPLETED	21	18
Maintenance Phase NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lac-hydrin + Ultravate Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks	Lac Hydrin + Placebo Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
Open- Label Phase Failed to be clear or almost cleared	14	0
Maintenance Phase Lost to Follow-up	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lac-hydrin + Ultravate n=21 Participants Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks	Lac Hydrin + Placebo n=20 Participants Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the maintenance phase, from 2 weeks up to 26 weeks

Population: The primary endpoint was a change in PGA during the 24 weeks of the study in the intention-to-treat population (ITT).

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.

Outcome measures

Outcome measures
Measure	Ammonium Lactate + Ultravate n=21 Participants ammonium lactate twice daily everyday plus ultravte ointment twice daily on weekends only for up to 24 weeks	Ammoium Lactate + Placebo n=20 Participants ammonium lactate twice daily everyday plus placebo ointment twice daily weekends only
Physical Global Assessment Category 0 or 1	12 participants	0 participants
Physical Global Assessment Category ≥ 2	9 participants	20 participants

SECONDARY outcome

Timeframe: During the maintenance phase, from 2 weeks up to 26 weeks

Population: The primary endpoint was a change in PGA during the 24 weeks of the study in the ITT.

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.

Outcome measures

Outcome measures
Measure	Ammonium Lactate + Ultravate n=21 Participants ammonium lactate twice daily everyday plus ultravte ointment twice daily on weekends only for up to 24 weeks	Ammoium Lactate + Placebo n=20 Participants ammonium lactate twice daily everyday plus placebo ointment twice daily weekends only
Signs of Psoriasis, Atrophy or Telangiectasis category 0 or 1	12 participants	0 participants
Signs of Psoriasis, Atrophy or Telangiectasis category ≥ 2	9 participants	20 participants

Adverse Events

Lac-hydrin + Ultravate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lac Hydrin + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason Emer, MD

Mount Siani School of Medicine Department of Dermatology

Phone: 2122413288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place