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CompletedNCT00913185Updated Jun 24, 2014

Comparison Study of Topical Acne Regimens

A Phase 4 interventional study of Acne Free, Proactiv in Acne, sponsored by MedDerm Associates. Completed at 1 site in United States. Open to participants aged 13 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-24.

Sponsored by MedDerm Associates · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
13 Years to 45 Years
Sex
All
01

Study summary

The purpose of this study is to compare the effectiveness of two over the counter acne products in subjects with moderate severity acne vulgaris. The two products being compared in this study are Acne Free "Severe Acne Line" manufactured by University Medical Products, and Proactiv® manufactured by Guthy-Renker.

Read the detailed description

You will receive a study drug for the 8 week study. No subject will be given a placebo (an inactive substance) during treatment.The study drugs (over the counter acne medications) have been previously tested and their safe use has been established. However, not all risks or side effects are known. In rare cases of allergy, side effects may be life threatening.The most common side effects of this study drug are:

  1. Dry skin
  2. Peeling skin
  3. Red skin
  4. Burning or tingling (temporary)
02

Conditions studied

  • Acne

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Keywords

  • Acne
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 85 are open to participants now.

This study's planned enrollment of 128 is above the median of 68 across 627 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

MedDerm Associates is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects and/or subjects' legal guardians who understand and are willing to sign an Informed Consent Form, an Assent Form if indicated, and a HIPAA Authorization Form.
  • Subjects who have received the permission of a parent or guardian to participate in this study or cannot be classified as a minor, under the age of 18 years.
  • Male and female subjects between the ages of 13 and 45 years and in generally good health, as determined by a Medical History Form.
  • Subjects with moderately-severe acne vulgaris of the face and neck as determined and defined by baseline lesion counts (see Definition: Acne Severity above).
  • Subjects who have completed a Medical History Form.
  • Subjects who have not used oral acne medications for 1 month prior to start of study, and topical acne medications 1 week prior to start of study.
  • Subjects who agree not to use any acne medication during the study except for the test materials given to them.
  • Subjects who agree not to use any make-up that contains acne treatment additives, such as benzoyl peroxide, salicylic acid or retinol.
  • Subjects who are willing to be photographed and video-recorded during study visits and willing to sign photographic release forms.
  • Subjects who exhibit dependability and intelligence in following directions.

Exclusion criteria

Exclusion Criteria:

  • Subjects who are pregnant or lactating.
  • Subjects with known allergies to cosmetic, toiletry, or acne treatment products.
  • Subjects who are sensitive to any of the ingredients in the test articles.
  • Subjects who have participated in a facial treatment study within 3 weeks of study initiation.
  • Subjects exhibiting acute or chronic dermatological, medical, and/or physical conditions which would preclude application of the test materials and/or influence the outcome of the study.
  • Subjects who are unable to sit quietly for 15 minutes to acclimate to ambient temperature and humidity conditions in the laboratory.
  • Male subjects who do not have a full beard.
  • Subjects who cannot stop usage of oral acne mediation 1 month prior to study start, and topical acne medications 1 week prior to study start.
  • Subjects taking routine high dosage anti-inflammatory medications (aspirin, ibuprofen).
  • Subjects who must use oral corticosteroids and/or oral immunosuppressive drugs (steroid inhalers or decongestant nose drops and/or eye drops are permitted).
  • Any condition for which the Investigator determines that the subject could be placed under undo risk.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
128 participants (estimated)

Interventions

  • DrugAcne Free, Proactiv
06

Study locations

1 site
  • MedDerm Associates
    San Diego, California 92103, United States
07

References and documents

Related links

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00913185
Lead sponsor
MedDerm Associates
Responsible party
Michelle Pelle, M.D. (Principal Investigator, MedDerm Associates) — Principal investigator
First posted
Jun 4, 2009
Start date
Dec 2006
Primary completion
Dec 2006
Completion
Feb 2008
Last update
Jun 24, 2014

Study contacts

Michelle T Pelle, M.D.
principal investigator · Medical Director

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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