Safety and efficacy comparison of minocycline microgranules vs lymecycline in the treatment of mild to moderate acne: randomized, evaluator-blinded, parallel, and prospective clinical trial for 8 weeks.

BACKGROUND: Minocycline and lymecycline are used in the treatment of acne, but there is not enough evidence to support superior efficacy of one of them. METHODS: 170 participants from 14 to 34 years old with mild to moderate facial acne vulgaris were recruited. 84 had 100 mg of minocycline in a single daily dose for 8 weeks and 86 had 300 mg of lymecycline in a single daily dose for 8 weeks. Participants were evaluated at baseline, week 4 and week 8. RESULTS: 65 minocycline and 60 lymecycline patients were evaluable. The last observation carried forward for the count of non-inflammatory lesions changed from 37.5 ± 17.8 to 37.7 ± 17.8 in the minocycline group and from 36.9 ± 15.5 to 33.4 ± 19.3 in the lymecycline group (no significant changes); corresponding changes in inflammatory lesions were from 19.4 ± 12.4 to 12.2 ± 10.0 in the minocycline group and from 20.1 ± 11.3 to 12.6 ± 8.4 in lymecycline group (P< 0.05 comparing baseline vs. final in both groups). Porphyrin counts varied from 899.5 ± 613.9 to 233.5 ± 219.5 in the minocycline group and from 956.9 ± 661.8 to 411.8 ± 411.5 in the lymecycline group (P<0.05 between the groups at study end). 36 (42.9%) patients receiving minocycline suffered 55 adverse events (22 of them gastrointestinal), while 28 (33.3%) lymecycline patients had 37 adverse events (15 of them gastrointestinal). One patient in the lymecycline group withdrew the study due to gastritis, and one more patient in the same group experienced eosinophilia. CONCLUSIONS: There were no differences between the groups in non-inflammatory and inflammatory lesion counts, and in the safety profile. Treatment with minocycline induced statistically significant decrease in facial porphyrin counts compared to the group treated with lymecycline (ClinicalTrials.gov number, NCT00988026).

Combination therapy with adapalene-benzoyl peroxide and oral lymecycline in the treatment of moderate to severe acne vulgaris: a multicentre, randomized, double-blind controlled study.

BACKGROUND: Oral antibiotics in association with a topical retinoid with or without benzoyl peroxide (BPO) are the recommended first-line option in the treatment of moderate to severe acne vulgaris. OBJECTIVES: To evaluate the efficacy and safety of oral lymecycline 300 mg with adapalene 0·1%-BPO 2·5% (A/BPO) fixed-dose gel in comparison with oral lymecycline 300 mg with a vehicle gel in subjects with moderate to severe acne vulgaris. METHODS: A total of 378 subjects were randomized in a double-blind, controlled trial to receive once-daily lymecycline with either A/BPO or vehicle for 12 weeks. Evaluations included percentage changes from baseline in lesion counts, success rate (subjects 'clear' or 'almost clear'), skin tolerability, adverse events and patients' satisfaction. RESULTS: The median percentage reduction from baseline in total lesion counts at week 12 was significantly higher (P < 0·001) in the lymecycline with A/BPO group (-74·1%) than in the lymecycline with vehicle group (-56·8%). The success rate was significantly higher (47·6% vs. 33·7%, P = 0·002) in subjects treated with lymecycline and A/BPO. Both inflammatory and noninflammatory lesions were significantly reduced at week 12 (both P < 0·001) with a rapid onset of action from week 2 for noninflammatory lesions (P < 0·001) and week 4 for inflammatory lesions (P = 0·005). The A/BPO and lymecycline combination was well tolerated. The proportion of satisfied and very satisfied subjects was similar in both groups, but the number in the A/BPO group who were 'very satisfied' was significantly greater (P = 0·031). CONCLUSION: These results demonstrate the clinical benefit of combining A/BPO with lymecycline in the treatment of moderate to severe acne vulgaris.

[Stevens-Johnson syndrome due to lymecycline]. / Syndrome de Stevens-Johnson à la lymécycline (Tétralysal).

BACKGROUND: Reports of severe drug-induced bullous reactions to tetracyclines are rare. A case of Stevens-Johnson syndrome in a patient treated with lymecycline is reported herein. CASE REPORT: A 22 year-old woman with acne was referred for Stevens-Johnson syndrome occurring ten days after starting lymecycline. The patient was initially treated with high doses of corticosteroid. She presented with severe oral and vulvar erosions and erosive cutaneous lesions involving 5 to 7% of the body surface area. Erosive cutaneous lesions progressively extended to 20-30% of the body surface area for a 27-day period. Histological analysis of a skin biopsy showed epidermal necrolysis typical of toxic epidermal necrolysis. Epithelialization of mucosal and cutaneous lesions was achieved 34 days after lymecycline withdrawal. CONCLUSION: Stevens-Johnson syndrome is an extremely rare reaction to lymecycline. The prolonged development of skin lesions seen here after lymecycline withdrawal despite the short half life of the drug is surprising. It could have been due to use of strong systemic corticosteroids, as described in certain other case reports.

Acné: nuevas tendencias / Acne: new tendencies

La acné es una enfermedad muy frecuente que aparece alrededor de la pubertad y se caracteriza por su polimorfismo lesional y su cronicidad. Se la divide en grados de severidad y según los mismos se determina la terapéutica adecuada. Tiene un alto impacto psicosocial en quienes la padecen por lo cual es muy importante el vínculo que se establece entre el paciente y su médico, lo cual redundará en una buena aceptación del tratamiento y una mejor respuesta por parte del paciente. En los últimos años se ha avanzado en el conocimiento de su etiopatogenia, lo cual permitió un entendimiento más profundo de la enfermedad. La tendencia actual es la de combinar diferentes drogas que tengan influencia sobre diferentes etiopatogénicos de la acné. Se ha comprobado que de este modo la respuesta es más rápida y el tratamiento menos tóxico (AU)

Lymecycline and minocycline in inflammatory acne: a randomized, double-blind intent-to-treat study on clinical and in vivo antibacterial efficacy.

BACKGROUND: Some antibiotics represent a mainstay in acne treatment. However, studies comparing their efficacies are rare. AIM: To evaluate the clinical and in vivo antibacterial effect of lymecycline and minocycline at different dosages. METHOD: Eighty-six patients with moderate to severe acne were enrolled in a randomized, double-blind, intent-to-treat study comparing in three parallel groups the effect of (1) lymecycline 300 mg daily for 12 weeks, (2) minocycline 50 mg daily for 12 weeks and (3) minocycline 100 mg daily for 4 weeks followed by 50 mg daily for 8 weeks. Evaluations were made at the screening visit and at five on-treatment visits. They consisted of clinical counts of acne lesions and evaluations of bacterial viability using dual flow cytometry performed on microorganisms collected from sebaceous infundibula by cyanoacrylate strippings. RESULTS: Patients receiving minocycline 100/50 mg had the best clinical outcome, particularly in the reduction of the number of papules. By the end of the trial, the microbial response to minocycline 100/ 50 mg was also superior to either of the other two treatments. There were less live and more dead bacteria. CONCLUSION: In this trial, minocycline 100/50 mg was superior for the treatment of inflammatory acne when compared to lymecycline 300 mg and minocycline 50 mg.

A comparison of the efficacy and safety of lymecycline and minocycline in patients with moderately severe acne vulgaris.

A multicentre, randomised, double-blind and double-dummy study was conducted to compare the efficacy and safety of lymecycline (n = 71) with that of minocycline (n = 73) in 144 patients with moderately severe acne vulgaris. Patients with an acne score of 1-5 on the Leeds scale received oral lymecycline, 300 mg/day for 2 weeks, then 150 mg/day for 10 weeks or oral minocycline, 100 mg/day for 2 weeks then 100 mg every other day for 10 weeks. Inflammatory, non-inflammatory and total lesion counts were determined at baseline (week 0) and after 4, 8 and 12 weeks' treatment, and global efficacy and safety assessments were made by the patient and investigator at the end of the study. Both treatments were equally effective at reducing differential lesion counts and improving acne condition and severity, with no significant differences between treatments. Inflammatory lesions were reduced by 50.6% and 52.2% with lymecycline and minocycline, respectively, and non-inflammatory lesions by 40.6% and 32.2%. Acne severity was reduced by 42.4% with lymecycline and by 47.9% with minocycline. A total of 4.3% of lymecycline recipients and 4.1% of minocycline recipients experienced treatment-related adverse events, the majority of which were mild in nature. Lymecycline was as effective as minocycline for the treatment of moderately severe acne vulgaris. Both treatments were well tolerated, although there were slightly fewer adverse gastrointestinal and dermatological effects with lymecycline.

Efficacy and safety of azithromycin versus lymecyline in the treatment of genital chlamydial infections in women.

To compare the clinical and microbiological efficacy of azithromycin in curing chlamydial infections in women with that of lymecycline, and with a view of the possibility of minimizing the problem of compliance by means of single-dose administration, 146 women with culture-positive Chlamydia trachomatis infections were randomly assigned to treatment with a 1 g bolus dose of azithromycin or a 10-day course of lymecycline 300 mg twice daily. Clinical and microbiological evaluations were performed and adverse effects monitored at check-ups after 15-35 and 40-65 days. Of the 146 patients enrolled in the study, 120 were evaluable. At the second check-up, C. trachomatis was found to have been eradicated in all patients in both treatment groups. Of the 51 patients who had clinical signs and symptoms of genital infection at enrolment, 96% (22/23) of those in the azithromycin group were considered cured (n = 18) or improved (n = 4), as compared with 100% (28/28) of those considered cured (n = 22) or improved (n = 6) in the lymecycline group. Adverse events related, or possibly related, to treatment were reported by 16 (21.6%) of the lymecycline group, but by only 6 (8.3%) of the azithromycin group. The 2 drugs were comparable with regard to microbiological and clinical efficacy in the treatment of genital chlamydial infection in women. The markedly lower rate of side-effects associated with azithromycin may be a feature conducive to patient compliance.

Differences in phototoxic potency should be considered when tetracyclines are prescribed during summer-time. A study on doxycycline and lymecycline in human volunteers, using an objective method for recording erythema.

In order to test the phototoxic potency of the two tetracyclines most frequently prescribed in Sweden, a double-blind cross-over study using a double-dummy technique with doxycycline 0.1 g twice daily, lymecycline 0.6 g twice daily, and placebo, was performed in 15 healthy volunteers. Drugs were given for 3 consecutive days, and on the third day volunteers were tested with 25, 50, 75 and 100 J/cm2 of artificial long-wave ultraviolet radiation (UVA), and assessed 6 h later for erythematous photoreactions. Objective readings were made using skin reflectance spectrophotometry. All three substances were tested in each individual at weekly intervals. Within 50, 75 and 100 J/cm2 of UVA, lymecycline showed a slight increase in erythema compared with placebo, but this was not significant (50 and 100 J/cm2), or was of low significance (75 J/cm2). However, with the same doses, doxycycline showed a substantial increase in erythema compared with placebo, which was highly significant. We conclude that doxycycline has a higher phototoxic potency than lymecycline, and this is in agreement with earlier in vitro experimental data. We recommend that therapy with doxycycline is avoided during summer-time, and during holidays in a sunny climate.

Double-blind, placebo-controlled study of three-month treatment with lymecycline in reactive arthritis, with special reference to Chlamydia arthritis.

We conducted a double-blind, placebo-controlled, randomized study of 3-month treatment with lymecycline, a form of tetracycline, in reactive arthritis (ReA). Lymecycline therapy significantly decreased the duration of the illness in patients with Chlamydia trachomatis-triggered ReA, but not in other ReA patients. In 2 ReA patients, C trachomatis was found in the throat, an uncommon locale for this organism. Our results suggest that it is important to verify the triggering microbe and that it is beneficial to treat Chlamydia arthritis patients with a prolonged course of tetracycline.

Comparative bioavailability of tetracycline and lymecycline.

The relative bioavailability of lymecycline and tetracycline hydrochloride was compared in 12 healthy volunteers in a double-blind cross-over study using a high performance liquid chromatographic method for plasma and urine analyses. A statistical significant difference in favour of tetracycline hydrochloride was found concerning the mean AUC and the mean lag time. The relative bioavailability of lymecycline was only 70% compared with tetracycline in multiple dosing (19.13 +/- 5.39 micrograms ml-1 h and 27.22 +/- 6.26 micrograms ml-1 h respectively) and 80% in a single dose (21.88 +/- 4.23 micrograms ml-1 h and 26.91 +/- 6.01 respectively) and the mean lag time of tetracycline was only 60% compared with lymecycline.

Tetracycline induced esophageal ulcers. a clinical and experimental study.

Medication with oral drugs has not been considered as a cause of esophageal lesions in the general literature of esophageal disease. This study demonstrates 40 patients with complaints of sudden onset of intense retrosternal pains and odynophagia during treatment with oral tetracyclines. All patients had distinct circumferential ulcers in the esophagus. Medical history, barium swallows, esophagoscopy, biopsies and esophageal manometry revealed no other apparent etiology but a local corrosive effect of the tetracyclines. Experimental tests on the esophagus of the cat verified a severe local corrosive effect of the tetracyclines. Another tetracycline, lymecycline, not reported previously to induce esophageal lesions in man, was significantly less ulcerogenic than doxycycline and oxytetracycline. Drug induced esophageal ulcerations are likely to be more numerous than previously suspected. The experimental model used appears to be sound for investigating ulcerogenic potentials of orally administered drugs.

[Lymecycline in the treatment of subacute sinusitis. Clinical study]. / Lymecycline in de behandeling van subakute sinusitis. Klinische studie.

After evaluation of the clinical efficacy and the tolerance of lymecycline 2 x 300 mg/day in patients with subacute sinusitis, we may conclude that lymecycline can be considered a first choice antibioticum in the treatment of acute and subacute sinusitis (Tetralysal).