Charm! and Experimental! Dt'mmtnl'ugr I933; Ll: 2+2 2-H.
`
`A comparison of doxycycline and minocycline in the
`treatment of acne vulgaris
`
`P. V. HARRlSON Beaumont Hospital. Shine Rom}. Lancaster LA1 2JF, UK
`
`xlrrt’ptedfijr publication 5 February “188
`
`Summary
`
`A ll—week, observer—blind, study compared doxycycline
`(50 mg daily) with minoeycline (50 mg twice daily] in the
`treatment of acne vulgaris in 43 patients. The analysis of
`data on 34 patients completing the study (15 receiving
`doxycycline and 19 receiving tninocycline) showed both
`treatments to be equally efl'ective, although the use of
`dosycycline had the advantage of it being a once—daily
`treatment
`regime. Doxycy cline, with minimal
`side
`effects, can be recommended for the treatment of acne
`vulgaris.
`
`Tetracyclines are a well established treatment for acne
`vulgaris and tloxycycline, at doses of SI] and 100 mg daily,
`has been shown to be effective in the condition.1 l
`
`Furthermore, dosycyclinc lllll mg daily has been shown
`to he as equally effective as minocycline [00 mg daily in a
`comparative study-1* The present study has examined the
`efficacy and tolerance of' dosycyclinc 50 mg daily com-
`pared with minocycline 50 mg twice daily used in the
`treatment of patients with acne vulgaris.
`
`Patients and Methods
`
`Forty-three patients entered the study, 22 males and 21
`Females, age range 16—35, mean 20 years. The demo-
`graphic data is shown on Table l. The patients were
`randomized to receive either doxycycline, ill mg daily, or
`tninot'yclinc, 50 mg twice daily. Twenty—one patients
`received doxycvcline and 32 patients received minocyc—
`line.
`
`All patients gave informed consent to participate in the
`study and exclusions
`included pregnant or nursing
`women and patients on an oral contraceptive pill. The
`same topical
`therapy was used for all patients, a 4”,,
`chlorhcxidine preparation and a 5”,, benzoyl peroxide
`preparation.
`:\t the patients‘ initial visit concomitant
`conditions and previous. or concomitant
`treatments,
`including those for acne, were recorded. The date of
`
`l’.\'.llarrison,
`Correspondence
`Lancaster [Al 2_Il". LI.
`
`Ilcaumotu llospital. Hlync Rd,
`
`242
`
`stripping previous antibiotic therapy was recorded if
`appropriate and no patient had received an antibiotic for
`at least four weeks prior to the start of the study. The
`patients were assesscdi by counting the number ofcysts,
`nodules, pustules and papules on the face, lesions further
`being classified as active or less active. Macules (resolving
`lesions) were also recorded. Lesions on the chin and neck
`anterior to sternomastoid muscles were included, but
`those on or around the nose and around the hairline were
`excluded. Patients with a moustache or a beard were
`
`excluded from the study and male patients were asked to
`shave prior to attendance at the clinic. Female patients
`were asked to remove makeup at
`least thirty minutes
`before assessment and all assessments were made by the
`same person (PVH).
`Patients had an initial assessment and were then
`
`reviewed after 4 weeks, b' weeks, and finally 12 weeks of
`treatment. The facial spot count was recorded at each
`visit. Any change in the number of lesions at the final
`assessment compared with base-line assessment was
`analysed for each of nine types of lesions for the total
`lesion count and for a total weighted score according to
`the severity of each type oflesion. A weighted score oil
`was given for active and less active papules, 4 for active
`and less active pustules,
`ID for active and less active
`nodules, and IS for active and less active cysts. Statistical
`analysis was by analysis ofcovariance and the chi«squared
`test. Patients were asked at each visit to assess the severity
`of their acne as a score out of “)0 on a 10 cm visual
`
`analogue scale. Any side effects of the treatment were
`assessed hy the question at each visit: ‘Has the treatment
`upset you in any way?‘ .‘\I the final visit, each patient had
`an assessment of their tolerance of treatment and the
`
`treatments‘ eltect upon their acne using a four-point scale
`marked ‘escellent‘, ‘good‘, ‘l'air‘, or ‘poor'.
`
`Results
`
`'l‘hirty—t‘our patients completed the study, 15 patients
`receiving doxycyclinc and 1‘) patients receiving minocyc-
`line. Nine patients were excluded from analysis, o in the
`dovycycline group and 3 in the minocycline group. In the
`
`Amneal 1044
`
`Amneal v. Supernus
`|PR2013-00368, 2013-00371 and
`2013-00372
`
`

`

`l'JOXYCYCLINli, MINOCYCIJNE AND ACNE VULGARIS
`
`243
`
`Table I. Demographic data on patients receiving dotycycline
`and minocycline
`
`Table 2. Percentage in acne score in patients receiving doxycyeline or
`rninocycline
`
`.'\ gt:
`
`w: (kg)
`
`Set
`
`(No. ol'pts)
`
`Mean Range Mean Range
`
`Driajrrjtvdtru' Croat/3
`Men
`(Ill)
`Women (ll)
`:‘ll
`(2i)
`
`2l'3
`195
`204
`
`(If) 29) 7o?
`(12 28)
`59-”
`(ll 29)
`b7-7
`
`38-5)
`(ho-ll
`(47b 63‘”)
`(474% 8311)
`
`,llmurvdtm' Group
`(52"? 7 llllll)
`72-6
`(Io—J4)
`Ill-ll
`Men
`(12)
`(Si-57 “0“”
`(H 35) Sfi'l
`Ell-l
`“'omen (Ill)
`
`
`
`
`
`(H 35) 67-7ill-ft(22):\ll (Si-5 llll~ll)
`
`doxyeline group, S withdrew from the trial, but one was
`excluded for starting the contraceptive pill during the
`trial. In the minocycline group, 2 patients withdrew from
`the trial and l was excluded for starting the contraceptive
`pill during the trial. Withdrawal from the trial was not
`related to side effects from the preparation or the lack of
`efficacy.
`Males and females were almost equally distributed in
`both treatment groups and the duration of acne prior to
`the study was the same for patients receiving doxycycline
`or minocycline. The duration of treatment in the dosy-
`cycline group ranged from ll— 14 weeks and in the
`minocycline group from [0715 weeks. However, most
`patients were treated for either 12 or l3 weeks.
`Patients’ assessment on the visual analogue scale and
`score ll-—lllll were found to be inconsistent and it was felt
`
`this type of data was insufficiently accurate to
`that
`compare the elfccts ol' the two drugs. However. aSscss-
`ment of severity of acne by a spot count was analysed in
`detail. The total number of lesions at base—line ranged
`from l5 to ()4 in the doxycycline group and from 9 to 103
`in the minncycline group. The reduction oi'mean lesion
`count
`for doxycyeline was
`from 44 to 19 and for
`minocycline was from so to 22. The mean reduction in
`the total adjusted lesions counted was 30 lesions in each
`treatment group which is 590.“ of the mean base-line
`value (Table 2 and Fig.
`l). The reduction of mean total
`lesion score was from 244 to 88 for doxycycline and for
`tninocycline from 307 to llll. The reductions in mean
`total adjusted lesion scores were l8~l in the doxycyclinc
`and lfi‘) in the minocycline—treated patients. representing
`respective reductions of'oh“., and fill“;i (Table 2 and Fig.
`l). The mean change in lesion Count and score was
`adjusted to account for different base—line values which is
`why these values were not equal to the mean base-line
`minus the mean final. The slightly higher percentage
`reduction in mean score compared with mean lesion
`count reflects the greater percentage reduction in the
`
`Difference
`
`Dosycyeline Minocyeline between duty—
`percentage
`percentage
`cycline and
`change
`change
`minocy cline
`
`7 59
`so
`
`7 73
`
`7 33
`
`— 73
`
`7 5‘3
`—os
`
`7 ill
`
`— 43
`
`— 75
`
`NS
`NS
`
`NS
`
`\l-‘i
`
`NS
`
`active
`
`less
`
`less active
`
`Total spot count
`Total score
`Total spot count
`lesions
`Total spot count 7
`active lesions
`Total score
`active
`lesions
`Total score
`lesions
`Cysts — active
`less active
`7 active
`less active
`active
`less active
`active
`less active
`
`Nodules
`
`Pustules
`
`NS
`7 57
`-— ill
`NS
`7 HI
`7 8‘)
`NS
`7 (18
`7 oil
`NS
`— 72
`7 73
`NS
`- till
`7 till
`NS
`-— 82
`-— 84
`NS
`7 2‘)
`— 37
`N5
`7 (a?
`7 h?
`NS
`30
`— IS
`N5
`+ 3’
`7 H
`Macules
`
`
`Papules
`
`NS 7 not significant.
`
`more severe types of lesions than in the less severe types.
`The mean changes in acne scores for the two treatment
`groups were very similar for all variables; although in
`general there was a slightly greater reduction in the mean
`number ofactivc lesions in the dosyeycline group and in
`less active lesions in the minocycline group, but
`the
`difference between the two groups was not statistically
`significant.
`The efficacy of treatment was considered to be good or
`excellent in 739", of patients in the dosycycline group
`compared with 84”“ in the minocycline group, but there
`was no statistical difference between the two groups ol‘
`patients. 'l‘olcrance was said to be excellent
`in S3”... of
`patients in the doxy cycline group and 37”., of patients in
`the minoeycline group. Only 7"“ of patients receiving
`doxycycline and 21‘},I of patients receiving minocyclinc
`reported tolerance to be less than good or excellent, and
`the difference between the two groups ol'patients was not
`statistically significant.
`There were only 4 patients in the doxycycline group
`and 3 in the rninocycline group who experienced side
`effects during the study. These were mostly not due to the
`antibiotic treatment, and only one patient in the doxycyc—
`line group experienced treatment—related side effects
`(abdominal pain) and 2 patients in the minocycline group
`(headache or drowsiness). The difference in side effects
`between the two groups of patients was not statistically
`significant.
`
`

`

`:-3
`OU
`
`CO
`
`'5(U
`_l
`
`EDU
`
`m C
`
`9in
`ID
`_I
`
`
`
`2-H-
`
`P.\".H}\RRIS()N
`
`Facial
`
`lesion cauni
`
`Discussion
`
`
`
`Mind
`Don”
`MmO'
`DOW'
`cycllne
`cycline
`cycI-ne
`cycline
`
`Baseline
`End of
`treatment
`
`'l‘etraeyclines are an effective treatment l'ur man _\' patients
`with acne vulgaris. The present repnrt has shown the
`efficacy of low-duse therapy with doxycycline. Minm'y‘c-
`line, 50 mg twice daily, is another useful therapy for acne
`and this study indicated that duxyeyciine. 50 mg once
`daily, is just as effective as mineeycline. 50 mg twice daily,
`with minimal side effects. Unitycycline has the advantage
`of at
`()nCC-dfiil)‘
`treatment regime and can be recum—
`mentled for the treatment nf acne.
`
`Acknowledgements
`
`I wish to thank Pfizer Pharmaceuticals Ltd fur
`
`the
`
`supplies ul‘tluxyeyeline.
`
`400
`
`Facuul
`
`Ieswon score
`
`References
`
`200
`
`300
`
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`
`Man‘
`Doxy-
`Mino-
`Doxy-
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`cycline
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`Eveline
`
`Baseline
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`
`Figure I. Drisyeyeline versus mimic) cline in the treatment ul‘acne
`vulgaris.
`
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`
`
`