NCT01628549 is a Phase 2 clinical trial of 50 mg P005672-HCl in Acne Vulgaris, sponsored by Almirall, S.A..

Who is sponsoring NCT01628549?

NCT01628549 is sponsored by Almirall, S.A..

What drugs are being tested in NCT01628549?

Interventions in NCT01628549: 50 mg P005672-HCl, Placebo, 100 mg P005672-HCl.

What condition does NCT01628549 study?

NCT01628549 studies Acne Vulgaris.

Is NCT01628549 still recruiting?

NCT01628549 is currently completed. Last updated 1 February 2019.

Are results published for NCT01628549?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-02-01 · How we verify

NCT01628549

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

Completed Phase 2 Results posted Last updated 1 February 2019

What this trial tests

Phase 2 trial testing 50 mg P005672-HCl in Acne Vulgaris in 285 participants. Completed in 31 January 2013.

Timeline

30 June 2012

Primary endpoint
16 November 2012

31 January 2013

Quick facts

Lead sponsor	Almirall, S.A.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	285
Start date	30 June 2012
Primary completion	16 November 2012
Estimated completion	31 January 2013
Sites	38 locations across United States

Drugs / interventions tested

50 mg P005672-HCl — full drug profile →
Placebo
100 mg P005672-HCl — full drug profile →

Conditions studied

Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Almirall, S.A. — full company profile →

Who can join

Adults 12 to 45, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit Primary · Baseline (Week 0) to Final Visit (Up to Week 12)

Group	Value	95% CI
Placebo	12.8	± 14.18
P005672-HCl Approximately 0.75 mg/kg/Day	14.4	± 13.01
P005672-HCl Approximately 1.5 mg/kg/Day	17.6	± 16.65
P005672-HCl Approximately 3.0 mg/kg/Day	17.1	± 11.69

The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit Primary · Final Visit (Up to Week 12)

The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.

Group	Value	95% CI
Placebo	8
P005672-HCl Approximately 0.75 mg/kg/Day	11
P005672-HCl Approximately 1.5 mg/kg/Day	17
P005672-HCl Approximately 3.0 mg/kg/Day	10
Placebo	64
P005672-HCl Approximately 0.75 mg/kg/Day	65
P005672-HCl Approximately 1.5 mg/kg/Day	53
P005672-HCl Approximately 3.0 mg/kg/Day	56

The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit Secondary · Baseline (Week 0) up to Week 12

Change from Baseline at Week 1

Group	Value	95% CI
Placebo	5.8	± 9.07
P005672-HCl Approximately 0.75 mg/kg/Day	5.4	± 9.28
P005672-HCl Approximately 1.5 mg/kg/Day	5.4	± 8.44
P005672-HCl Approximately 3.0 mg/kg/Day	5.9	± 8.33

Change from Baseline at Week 2

Group	Value	95% CI
Placebo	8.4	± 10.13
P005672-HCl Approximately 0.75 mg/kg/Day	8.5	± 10.02
P005672-HCl Approximately 1.5 mg/kg/Day	8.2	± 14.45
P005672-HCl Approximately 3.0 mg/kg/Day	9.7	± 11.30

Change from Baseline at Week 4

Group	Value	95% CI
Placebo	10.9	± 10.04
P005672-HCl Approximately 0.75 mg/kg/Day	9.3	± 13.84
P005672-HCl Approximately 1.5 mg/kg/Day	11.7	± 15.36
P005672-HCl Approximately 3.0 mg/kg/Day	12.8	± 9.96

Change from Baseline at Week 8

Group	Value	95% CI
Placebo	12.6	± 12.57
P005672-HCl Approximately 0.75 mg/kg/Day	13.1	± 11.89
P005672-HCl Approximately 1.5 mg/kg/Day	15.0	± 16.66
P005672-HCl Approximately 3.0 mg/kg/Day	14.3	± 12.90

Change from Baseline at Week 12

Group	Value	95% CI
Placebo	12.8	± 14.18
P005672-HCl Approximately 0.75 mg/kg/Day	14.3	± 13.00
P005672-HCl Approximately 1.5 mg/kg/Day	17.6	± 16.65
P005672-HCl Approximately 3.0 mg/kg/Day	17.1	± 11.69

Change from Baseline at Final Visit(Up to Week 12)

Group	Value	95% CI
Placebo	12.8	± 14.18
P005672-HCl Approximately 0.75 mg/kg/Day	14.4	± 13.01
P005672-HCl Approximately 1.5 mg/kg/Day	17.6	± 16.65
P005672-HCl Approximately 3.0 mg/kg/Day	17.1	± 11.69

The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Secondary · Baseline (Week 0) up to Week 12

Change from Baseline at Week 1

Group	Value	95% CI
Placebo	5.4	± 12.99
P005672-HCl Approximately 0.75 mg/kg/Day	3.8	± 14.28
P005672-HCl Approximately 1.5 mg/kg/Day	4.3	± 14.10
P005672-HCl Approximately 3.0 mg/kg/Day	5.1	± 13.83

Change from Baseline at Week 2

Group	Value	95% CI
Placebo	10.6	± 16.02
P005672-HCl Approximately 0.75 mg/kg/Day	9.4	± 13.58
P005672-HCl Approximately 1.5 mg/kg/Day	7.8	± 16.92
P005672-HCl Approximately 3.0 mg/kg/Day	7.9	± 14.24

Change from Baseline at Week 4

Group	Value	95% CI
Placebo	13.0	± 24.17
P005672-HCl Approximately 0.75 mg/kg/Day	10.0	± 17.25
P005672-HCl Approximately 1.5 mg/kg/Day	9.9	± 20.58
P005672-HCl Approximately 3.0 mg/kg/Day	12.7	± 15.24

Change from Baseline at Week 8

Group	Value	95% CI
Placebo	16.9	± 22.52
P005672-HCl Approximately 0.75 mg/kg/Day	14.3	± 21.44
P005672-HCl Approximately 1.5 mg/kg/Day	14.0	± 22.22
P005672-HCl Approximately 3.0 mg/kg/Day	15.2	± 19.04

Change from Baseline at Week 12

Group	Value	95% CI
Placebo	17.8	± 21.63
P005672-HCl Approximately 0.75 mg/kg/Day	17.9	± 19.85
P005672-HCl Approximately 1.5 mg/kg/Day	19.1	± 22.33
P005672-HCl Approximately 3.0 mg/kg/Day	17.0	± 21.56

Change from Baseline at Final Visit(Up to Week 12)

Group	Value	95% CI
Placebo	17.8	± 21.63
P005672-HCl Approximately 0.75 mg/kg/Day	17.9	± 19.83
P005672-HCl Approximately 1.5 mg/kg/Day	19.1	± 22.33
P005672-HCl Approximately 3.0 mg/kg/Day	17.0	± 21.56

The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Secondary · Baseline (Week 0) up to Week 12

Change from Baseline at Week 1

Group	Value	95% CI
Placebo	19.3	± 27.82
P005672-HCl Approximately 0.75 mg/kg/Day	17.2	± 28.43
P005672-HCl Approximately 1.5 mg/kg/Day	17.8	± 26.39
P005672-HCl Approximately 3.0 mg/kg/Day	19.4	± 26.17

Change from Baseline at Week 2

Group	Value	95% CI
Placebo	25.6	± 29.02
P005672-HCl Approximately 0.75 mg/kg/Day	26.4	± 32.60
P005672-HCl Approximately 1.5 mg/kg/Day	25.8	± 36.16
P005672-HCl Approximately 3.0 mg/kg/Day	30.6	± 35.88

Change from Baseline at Week 4

Group	Value	95% CI
Placebo	34.1	± 28.84
P005672-HCl Approximately 0.75 mg/kg/Day	29.3	± 38.90
P005672-HCl Approximately 1.5 mg/kg/Day	34.1	± 35.27
P005672-HCl Approximately 3.0 mg/kg/Day	40.0	± 31.83

Change from Baseline at Week 8

Group	Value	95% CI
Placebo	37.9	± 35.60
P005672-HCl Approximately 0.75 mg/kg/Day	39.8	± 34.47
P005672-HCl Approximately 1.5 mg/kg/Day	44.3	± 37.99
P005672-HCl Approximately 3.0 mg/kg/Day	44.5	± 37.62

Change from Baseline at Week 12

Group	Value	95% CI
Placebo	39.1	± 43.00
P005672-HCl Approximately 0.75 mg/kg/Day	43.3	± 39.70
P005672-HCl Approximately 1.5 mg/kg/Day	53.6	± 37.65
P005672-HCl Approximately 3.0 mg/kg/Day	53.5	± 35.18

Change from Baseline at Final Visit(Up to Week 12)

Group	Value	95% CI
Placebo	39.1	± 43.00
P005672-HCl Approximately 0.75 mg/kg/Day	43.5	± 39.72
P005672-HCl Approximately 1.5 mg/kg/Day	53.6	± 37.65
P005672-HCl Approximately 3.0 mg/kg/Day	53.5	± 35.18

The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Secondary · Baseline (Week 0) up to Week 12

Change from Baseline at Week 1

Group	Value	95% CI
Placebo	9.7	± 24.07
P005672-HCl Approximately 0.75 mg/kg/Day	7.7	± 26.87
P005672-HCl Approximately 1.5 mg/kg/Day	8.3	± 25.20
P005672-HCl Approximately 3.0 mg/kg/Day	10.6	± 25.63

Change from Baseline at Week 2

Group	Value	95% CI
Placebo	19.0	± 28.36
P005672-HCl Approximately 0.75 mg/kg/Day	16.7	± 24.99
P005672-HCl Approximately 1.5 mg/kg/Day	14.6	± 30.57
P005672-HCl Approximately 3.0 mg/kg/Day	16.0	± 30.37

Change from Baseline at Week 4

Group	Value	95% CI
Placebo	25.0	± 37.78
P005672-HCl Approximately 0.75 mg/kg/Day	18.3	± 33.17
P005672-HCl Approximately 1.5 mg/kg/Day	19.2	± 35.60
P005672-HCl Approximately 3.0 mg/kg/Day	25.7	± 29.27

Change from Baseline at Week 8

Group	Value	95% CI
Placebo	30.5	± 40.69
P005672-HCl Approximately 0.75 mg/kg/Day	26.1	± 38.84
P005672-HCl Approximately 1.5 mg/kg/Day	27.5	± 38.54
P005672-HCl Approximately 3.0 mg/kg/Day	30.4	± 38.45

Change from Baseline at Week 12

Group	Value	95% CI
Placebo	35.3	± 35.32
P005672-HCl Approximately 0.75 mg/kg/Day	34.3	± 36.40
P005672-HCl Approximately 1.5 mg/kg/Day	37.2	± 38.44
P005672-HCl Approximately 3.0 mg/kg/Day	32.8	± 42.59

Change from Baseline at Final Visit(Up to Week 12)

Group	Value	95% CI
Placebo	35.3	± 35.32
P005672-HCl Approximately 0.75 mg/kg/Day	34.1	± 36.28
P005672-HCl Approximately 1.5 mg/kg/Day	37.2	± 38.44
P005672-HCl Approximately 3.0 mg/kg/Day	32.8	± 42.59

The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Secondary · Baseline to Final Visit (Up to Week 12)

Week 1

Group	Value	95% CI
Placebo	0
P005672-HCl Approximately 0.75 mg/kg/Day	3
P005672-HCl Approximately 1.5 mg/kg/Day	0
P005672-HCl Approximately 3.0 mg/kg/Day	1
Placebo	72
P005672-HCl Approximately 0.75 mg/kg/Day	73
P005672-HCl Approximately 1.5 mg/kg/Day	70
P005672-HCl Approximately 3.0 mg/kg/Day	65

Week 2

Group	Value	95% CI
Placebo	2
P005672-HCl Approximately 0.75 mg/kg/Day	3
P005672-HCl Approximately 1.5 mg/kg/Day	2
P005672-HCl Approximately 3.0 mg/kg/Day	2
Placebo	70
P005672-HCl Approximately 0.75 mg/kg/Day	73
P005672-HCl Approximately 1.5 mg/kg/Day	68
P005672-HCl Approximately 3.0 mg/kg/Day	64

Week 4

Group	Value	95% CI
Placebo	1
P005672-HCl Approximately 0.75 mg/kg/Day	2
P005672-HCl Approximately 1.5 mg/kg/Day	0
P005672-HCl Approximately 3.0 mg/kg/Day	4
Placebo	71
P005672-HCl Approximately 0.75 mg/kg/Day	74
P005672-HCl Approximately 1.5 mg/kg/Day	70
P005672-HCl Approximately 3.0 mg/kg/Day	62

Week 8

Group	Value	95% CI
Placebo	6
P005672-HCl Approximately 0.75 mg/kg/Day	6
P005672-HCl Approximately 1.5 mg/kg/Day	8
P005672-HCl Approximately 3.0 mg/kg/Day	11
Placebo	66
P005672-HCl Approximately 0.75 mg/kg/Day	70
P005672-HCl Approximately 1.5 mg/kg/Day	62
P005672-HCl Approximately 3.0 mg/kg/Day	55

Week 12

Group	Value	95% CI
Placebo	8
P005672-HCl Approximately 0.75 mg/kg/Day	11
P005672-HCl Approximately 1.5 mg/kg/Day	17
P005672-HCl Approximately 3.0 mg/kg/Day	10
Placebo	64
P005672-HCl Approximately 0.75 mg/kg/Day	65
P005672-HCl Approximately 1.5 mg/kg/Day	53
P005672-HCl Approximately 3.0 mg/kg/Day	56

Final Visit (Up to Week 12)

Group	Value	95% CI
Placebo	8
P005672-HCl Approximately 0.75 mg/kg/Day	11
P005672-HCl Approximately 1.5 mg/kg/Day	17
P005672-HCl Approximately 3.0 mg/kg/Day	10
Placebo	64
P005672-HCl Approximately 0.75 mg/kg/Day	65
P005672-HCl Approximately 1.5 mg/kg/Day	53
P005672-HCl Approximately 3.0 mg/kg/Day	56

Adverse events — posted to ClinicalTrials.gov

Time frame: From Screening (up to week -12) to Week 12 plus 30 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/73 (0%)

Deaths: —

P005672-HCl Approximately 0.75 mg/kg/Day

Serious: 0/76 (0%)

Deaths: —

P005672-HCl Approximately 1.5 mg/kg/Day

Serious: 0/70 (0%)

Deaths: —

P005672-HCl Approximately 3.0 mg/kg/Day

Serious: 0/66 (0%)

Deaths: —

Other adverse events (3 terms — click to expand)

Reaction	System	Placebo	P005672-HCl Approximately …	P005672-HCl Approximately …	P005672-HCl Approximately …
Headache	Nervous system disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—

Data from ClinicalTrials.gov NCT01628549 adverse events section.

Sponsor's own description

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances.
Vasam M, Korutla S, Bohara RA. · · 2023 · cited 71× · PMID 38076662 · DOI 10.1016/j.bbrep.2023.101578
Sarecycline: First Global Approval.
Deeks ED. · · 2019 · cited 28× · PMID 30659422 · DOI 10.1007/s40265-019-1053-4

Verify or expand the search:

Other recruiting trials for Acne Vulgaris

Currently open trials in the same condition.

NCT07341087 — Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial · NA · recruiting
NCT07474883 — Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris · EARLY_PHASE1 · recruiting
NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
NCT07102186 — Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris · Phase 4 · recruiting

Other Almirall, S.A. trials

Trials by the same sponsor.

NCT07471932 — A Study of LAD106 in Healthy Adult Participants · Phase 1 · recruiting
NCT07311564 — A Study of LAD603 in Adults With Alopecia Areata · Phase 2 · recruiting
NCT06135415 — A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis · Phase 3 · completed
NCT06200597 — A Single and Multiple Ascending Dose Study of LAD603 in Healthy Subjects · Phase 1 · completed
NCT05990725 — Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01628549 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Almirall, S.A.
Last refreshed: 1 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01628549.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01628549

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Acne Vulgaris

Other Almirall, S.A. trials

Verify against primary sources