Trial Outcomes & Findings for The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis (NCT NCT01139580)

NCT ID: NCT01139580

Last Updated: 2017-01-18

Results Overview

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 363 participants
• Primary outcome timeframe: Week 8
• Results posted on: 2017-01-18

Participant Flow

Participant milestones

Measure	Calcipotriene Foam Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.	Vehicle Foam Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Overall Study STARTED	181	182
Overall Study COMPLETED	158	164
Overall Study NOT COMPLETED	23	18

Reasons for withdrawal

Measure	Calcipotriene Foam Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.	Vehicle Foam Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Overall Study Adverse Event	5	4
Overall Study Lost to Follow-up	9	1
Overall Study Lack of Efficacy	0	2
Overall Study Withdrawal by Subject	6	9
Overall Study Used Excluded Medicine After Enrollment	1	0
Overall Study Did Not Meet Exclusion Criteria	1	0
Overall Study Misrandomized	1	0
Overall Study Beginning Study Exclusion Treatment	0	1
Overall Study Participant Randomization in Error	0	1

Baseline Characteristics

The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis

Baseline characteristics by cohort

Measure	Calcipotriene Foam n=181 Participants Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 Participants Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Total n=363 Participants Total of all reporting groups
Age, Continuous	45.9 Years STANDARD_DEVIATION 15.3 • n=5 Participants	44.4 Years STANDARD_DEVIATION 15.5 • n=7 Participants	45.2 Years STANDARD_DEVIATION 15.4 • n=5 Participants
Gender Female	69 Participants n=5 Participants	76 Participants n=7 Participants	145 Participants n=5 Participants
Gender Male	112 Participants n=5 Participants	106 Participants n=7 Participants	218 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Black	15 participants n=5 Participants	18 participants n=7 Participants	33 participants n=5 Participants
Race/Ethnicity, Customized Multiracial	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized White	156 participants n=5 Participants	160 participants n=7 Participants	316 participants n=5 Participants
Race/Ethnicity, Customized Missing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Intent-to-Treat (ITT) Population: all participants who were randomized and dispensed study product. Missing values at Week 8 were considered to be failures. Failures were those participants who did not achieve a 2-grade improvement in IGSA score and a score of 0 or 1.

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

Outcome measures

Measure	Calcipotriene Foam n=181 Participants Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 Participants Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method	74 participants	44 participants

PRIMARY outcome

Timeframe: Week 8

Population: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant will be used to estimate subsequent missing data points).

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

Outcome measures

Measure	Calcipotriene Foam n=181 Participants Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 Participants Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)	75 participants	45 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: ITT Population

Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of erythema, hyperpigmentation may be present; 1, faint erythema; 2, light-red coloration; 3, moderate red coloration; 4, bright-red coloration; 5, dusky to deep red coloration.

Outcome measures

Measure	Calcipotriene Foam n=181 Participants Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 Participants Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8	42 participants	30 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: ITT Population

Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates.

Outcome measures

Measure	Calcipotriene Foam n=181 Participants Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 Participants Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8	53 participants	38 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: ITT Population

Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges.

Outcome measures

Measure	Calcipotriene Foam n=181 Participants Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 Participants Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8	67 participants	53 participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT Population. Data were analyzed using the failure and LOCF methods.

The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions.

Outcome measures

Measure	Calcipotriene Foam n=181 Participants Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 Participants Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 LOCF	33 participants	28 participants
Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8 Failure method	32 participants	28 participants

Adverse Events

Calcipotriene Foam

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Vehicle Foam

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Calcipotriene Foam n=181 participants at risk Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 participants at risk Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
General disorders Chest discomfort	0.00% 0/181	0.55% 1/182
Hepatobiliary disorders Cholecystitis acute	0.00% 0/181	0.55% 1/182
Injury, poisoning and procedural complications Multiple fractures	0.55% 1/181	0.00% 0/182
Psychiatric disorders Alcohol abuse	0.00% 0/181	0.55% 1/182

Other adverse events

Measure	Calcipotriene Foam n=181 participants at risk Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.	Vehicle Foam n=182 participants at risk Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
General disorders Application site pruritus	3.9% 7/181	3.8% 7/182
General disorders Application site pain	4.4% 8/181	2.7% 5/182
General disorders Application site erythema	2.8% 5/181	0.00% 0/182
Skin and subcutaneous tissue disorders Erythema	2.8% 5/181	0.00% 0/182
Infections and infestations Nasopharyngitis	0.00% 0/181	2.7% 5/182
General disorders Application site dermatitis	2.2% 4/181	0.00% 0/182
Skin and subcutaneous tissue disorders Skin burning sensation	2.2% 4/181	0.00% 0/182
Infections and infestations Upper respiratory tract infection	0.00% 0/181	2.2% 4/182

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER