Evaluation of the efficacy and safety of a new gel containing 10 mg/g Clindamycin and 0.25 mg/g Tretinoin vs. the originator Acnatac(R) 10 mg/g + 0.25 mg/Gel (Reference) vs. vehicle in patients with papulopustular acne

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dermapharm AG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

14 May 2024 → ongoing

Decision date (initial)

2024-04-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Dermapharm AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To compare the efficacy of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac(R) 10 mg/g + 0.25 mg/g Gel vs. vehicle in reducing inflammatory and total lesions at Day 84± 4

Secondary objectives 8

1. To compare the efficacy of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac® 10 mg/g + 0.25 mg/g Gel vs. vehicle in reducing non-inflammatory lesions at Day 84± 4
2. To compare the efficacy of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac® 10 mg/g + 0.25 mg/g Gel vs. vehicle in reducing inflammatory lesions, non-inflammatory lesions and total lesions at all other time points
3. To compare the efficacy of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac® 10 mg/g + 0.25 mg/g Gel vs. vehicle in reducing inflammatory lesions, non-inflammatory lesions and total lesions at Day 84 ± 4 and at all other time points
4. To compare the efficacy of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac® 10 mg/g + 0.25 mg/g Gel vs. vehicle in achieving clinical response of “success” at Day 84 ± 4
5. To compare the efficacy of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac® 10 mg/g + 0.25 mg/g Gel vs. vehicle in changing of the IGA
6. To compare the efficacy of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac® 10 mg/g + 0.25 mg/g Gel vs. vehicle on the overall therapeutic success
7. To compare the safety of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac® 10 mg/g + 0.25 mg/g Gel vs. vehicle
8. To compare the tolerability of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) vs. Acnatac® 10 mg/g + 0.25 mg/g Gel vs. vehicle

Conditions and MedDRA coding

Papulopustular acne

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Women, men and adolescents of both sexes ≥ 12 and ≤ 65 years of age
2. Written consent to study participation after patient information by the investigator
3. In case of patients below the age of 18: Written consent to study participation of legal guardian(s) and adolescent patient after an age-appropriate patient- and legal guardian(s)- information session by the investigator
4. Diagnosis of papulopustular acne according to generally accepted criteria
5. On the face, ≥ 25 non-inflammatory lesions (i.e. open and closed comedones) and ≥ 20 inflammatory lesions (e.g. papules and pustules), thereof ≤ 2 nodular lesions
6. Investigator`s Global Assessment (IGA) of acne severity grade 2,3 or 4
7. For women of childbearing potential: Application of an established highly efficient contraceptive method during the whole study
8. For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start. The urine pregnancy test used must have a sensitivity down at least 25 mIU/ml for human chorionic gonadotrophin (hCG) (High sensitivity pregnancy test)

Exclusion criteria 18

1. History or presence of Crohn`s disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis
2. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis)
3. Presence of pustular and deep cystic nodular acne lesions in the face (acne conglobata and acne fulminans)
4. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris
5. Presence of skin cancer in his/her own history
6. Known intolerance or hypersensitivity against clindamycin, tretinoin or lincomycin or any of the other ingredients in the study medication
7. Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoine) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
8. Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy, when taken, must remain constant throughout the study
9. Use on the face within 30 days prior baseline or during the study of 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy
10. Use within 30 days prior to baseline of: 1) spironolactone, 2) systemic glucocorticoids, 3) systemic antibiotics or 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-months washout)
11. Use within 14 days prior to baseline in the face of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents or 5) topical antibiotics
12. Other severe acute or chronic concomitant disease with severe impairment of the general condition
13. Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
14. Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
15. Reasonable doubt concerning the co-operation of the patient
16. Participation in another clinical study within the last 30 days prior to inclusion in this study
17. Participation in this study at an earlier date
18. Women with existing or intended pregnancy or during lactation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary efficacy endpoints to be analysed are the percent change in inflammatory lesion count from baseline (Day 0) to week 12 (Day 84) as well as the percent change in total lesion count from baseline (Day 0) to week 12 (Day 84)

Secondary endpoints 8

1. Percent change from baseline (Visit 1) to Visit 8 (EoT) assessed by the non-inflammatory lesion count as well as the total lesion count
2. Percent change in inflammatory lesion count, non-inflammatory lesion count and total lesion count between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, respectively
3. Absolute changes in inflammatory lesion count, non-inflammatory lesion count and total lesion count between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7 and Visit 8, respectively
4. Proportion of subjects with a clinical response of “success”, i.e. an IGA score of at least 2 grades less than the baseline assessment, at Visit 8.
5. Change of the Investigator`s Global Assessment (IGA) between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7 and Visit 8, respectively. Changes will be calculated as baseline- follow-up.
6. Evaluation of the overall therapeutic success by the investigator and patient at Visit 8
7. Incidence of adverse events (AEs) during the course of the study
8. Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EoT)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dermapharm AG

Sponsor organisation

Dermapharm AG

Address

Lil-Dagover-Ring 7, Geiselgasteig Geiselgasteig

City

Gruenwald

Postcode

82031

Country

Germany

Scientific contact point

Organisation

Dermapharm AG

Contact name

Department of Clinical Research

Public contact point

Organisation

Dermapharm AG

Contact name

Department of Clinical Research

Third parties 2

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications